Jan 26 (Reuters) – New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.
U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.
The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy.
Earlier this month, U.S. health officials said they had detected the possible link to ischemic strokes in people over age 65 who received the newer booster shots in its Vaccine Safety Datalink (VSD) database. They said at the time it was very unlikely to represent a true clinical risk.
Dr. Nicola Klein of healthcare company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.
Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said.
FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time.
Both agencies still recommend older adults receive the booster shots, now tailored to target Omicron variants as well as the original coronavirus.
Dr. Walid Gellad, professor of medicine at University of Pittsburgh, said the issue required further investigation.
“Sometimes signals are not clear,” Gellad said in an email. “It makes sense to look into it more, and it doesn’t make sense to change practice given the known benefits (of getting the booster) in this age group.”
(This story has been corrected to fix the name to Nicola from Nicole in paragraph 5)
Reporting by Michael Erman; Editing by Bill Berkrot
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Jan 7 (Reuters) – The U.S. Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease.
Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full FDA approval of the drug.
The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aims to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
Nearly all previous experimental drugs using the same approach had failed.
“Today’s news is incredibly important,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “Our years of research into what is arguably the most complex disease humans face is paying off and it gives us hope that we can make Alzheimer’s not just treatable, but preventable.”
Eisai said the drug would launch at an annual price of $26,500. Biogen shares, which had been halted, were up 3% at $279.40.
The Japanese company said it also plans to apply for marketing authorization for Leqembi in Japan and the European Union by the end of its business year on March 31.
Eisai estimated the number of U.S. patients eligible for the drug would reach around 100,000 within three years, increasing gradually from there over the medium to long term.
Dr. Erik Musiek, A Washington University neurologist at Barnes-Jewish Hospital, said he was “pleasantly surprised” by the drug’s price.
“Considering the marketplace and the fact that we have no other good disease-modifying treatments, I think it’s in the ballpark of what I would expect,” he said.
Initial patient access will be limited by a number of factors including reimbursement restrictions by Medicare, the U.S. government insurance program for Americans aged 65 and older who represent some 90% of individuals likely to be eligible for Leqembi.
“Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage … access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket,” the Alzheimer’s Association said in a statement.
Leqembi was approved under the FDA’s accelerated review process, an expedited pathway that speeds access to a drug based on its impact on underlying disease-related biomarkers believed to predict a clinical benefit.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s instead of only treating the symptoms of the disease,” FDA neuroscience official Billy Dunn said in a statement.
CMS said on Friday that current coverage restrictions for drugs approved under the accelerated pathway could be reconsidered based on its ongoing review of available information.
If the drug receives traditional FDA approval, CMS said it would provide broader coverage. Eisai officials have said the company plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi.
The CMS decision was largely in response to a previous Alzheimer’s treatment from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, won accelerated approval in 2021 with little evidence that the drug slowed cognitive decline and despite objections by the FDA’s outside experts.
Biogen initially priced Aduhelm at $56,000 per year before cutting the price in half. With limited acceptance and insurance coverage, sales were only $4.5 million in the first nine months of 2022.
Lecanemab is intended for patients with mild cognitive impairment or early Alzheimer’s dementia, a population that doctors believe represents a small segment of the estimated 6 million Americans currently living with the memory-robbing illness.
To receive the treatment, patients will need to undergo testing to show they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They will also need to undergo periodic MRI scans to monitor for brain swelling, a potentially serious side effect associated with this type of drug.
The medicine’s label says doctors should exercise caution if lecanemab patients are given blood clot preventers. This could be a safety risk, according to an autopsy analysis published this week of a lecanemab patient who had a stroke and later died.
In the large trial of lecanemab, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s by 27% compared to a placebo. Nearly 13% of patients treated with Leqembi in the trial had brain swelling.
Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, said the approval will make a “big difference” in the field because it is based on biomarkers rather than just symptoms.
“It’s going to change how we make a diagnosis for Alzheimer’s disease, with more accuracy,” he said.
Tousi acknowledged that the benefit of the drug will likely be modest. “Still, it is a benefit that we were not able to achieve” before this approval.
Reporting by Deena Beasley in Los Angeles and Bhanvi Satija in Bengaluru, additional reporting Jaiveer Shekhawat; Editing by Bill Berkrot, David Gregorio and William Mallard
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CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.
A combination of Moderna’s personalized cancer vaccine and Merck & Co’s (MRK.N) blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.
The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.
Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck’s shares rose 1%. Shares of BioNTech SE (22UAy.DE), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc (GRTS.O), which has a cancer vaccine in development, jumped 20% to $3.09.
The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.
“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.
Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the capacity to be a new paradigm in the treatment of cancer.”
The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.
The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.
A PROMISING FIELD
In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.
The personalized vaccine works in concert with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.
To build the vaccine, researchers took samples of patients’ tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.
When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.
Moderna’s personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.
Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.
Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.
Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.
Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.
“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.
Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.
Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Bill Berkrot
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LONDON, Dec 9 (Reuters) – Increased drug resistance in bacteria causing bloodstream infections, including against last-resort antibiotics, was seen in the first year of the coronavirus pandemic, a World Health Organization report based on data from 87 countries in 2020 showed.
The overuse and/or misuse of antibiotics has helped microbes to become resistant to many treatments, while the pipeline of replacement therapies in development is alarmingly sparse.
High levels (above 50%) of resistance have been reported in bacteria that typically cause life-threatening bloodstream infections in hospitals such as Klebsiella pneumoniae and Acinetobacter spp, report authors highlighted on Friday.
These infections often require treatment with ‘last-resort’ antibiotics, drugs that are used when all other antibiotics fail.
About 8% of bloodstream infections caused by Klebsiella pneumoniae grew resistant to a vital last-resort group of drugs called carbapenems, the report said.
Rates of antimicrobial resistance (AMR) remain very high, but last-resort antibiotics are only just starting to lose potency, said Dr Carmem Pessoa-Silva, the lead for WHO Global Antimicrobial Resistance Surveillance System, in a media conference.
The message of hope, she said is, “we have a very narrow window of opportunity…for responding to the threat.”
While there is a concerted push to limit the unbridled use of antibiotics, the pace of new research remains grim.
The effort, cost and time it takes to get an antibiotic approved and the limited return on investment have deterred drugmakers, as treatments must be priced cheaply and are designed to be used as little as possible to limit drug resistance.
As a result, the lion’s share of antibiotic development is taking place in a handful of labs of small biopharma companies as a majority of their larger counterparts focus on more lucrative markets.
Only a few big pharmaceutical companies remain in the space — including GSK (GSK.L) and Merck (MRK.N) — down from more than 20 in the 1980s.
A landmark global analysis published earlier this year found that 1.2 million people died in 2019 due to antibiotic-resistant bacterial infections, making AMR a leading cause of death worldwide, higher than HIV/AIDS or malaria.
“Political commitment (on AMR) must now urgently move from aspiration into action,” said Thomas Cueni, director general at International Association of Pharmaceutical Manufacturers and Associations.
The authors of the WHO report said more research is needed to identify the reasons behind the jump in AMR in the period studied, and to what extent it is linked to the accelerated use of antibiotics during the pandemic.
AMR rates also remain difficult to interpret due to insufficient testing and weak laboratory capacity, particularly in low- and middle-income countries, the authors wrote.
Reporting by Natalie Grover in London; Editing by Barbara Lewis and Arun Koyyur
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Nov 23 (Reuters) – There is now an imminent threat of measles spreading in various regions globally, as COVID-19 led to a steady decline in vaccination coverage and weakened surveillance of the disease, the World Health Organization (WHO) and the U.S. public health agency said on Wednesday.
Measles is one of the most contagious human viruses and is almost entirely preventable through vaccination. However, it requires 95% vaccine coverage to prevent outbreaks among populations.
A record high of nearly 40 million children missed a measles vaccine dose in 2021 due to hurdles created by the COVID pandemic, the WHO and the U.S. Centers for Disease Control and Prevention (CDC) said in a joint report.
While measles cases have not yet gone up dramatically compared to previous years, now is the time to act, the WHO’s measles lead, Patrick O’Connor, told Reuters.
“We are at a crossroads,” he said on Tuesday. “It is going to be a very challenging 12-24 months trying to mitigate this.”
A combination of factors like lingering social distancing measures and cyclical nature of measles may explain why there has not yet been an explosion of cases despite the widening immunity gaps, but that could change quickly, said O’Connor, pointing out the highly contagious nature of the disease.
The WHO has already seen an increase of large disruptive outbreaks since the start of 2022, rising from 19 to almost 30 by September, O’Connor said, adding that he was particularly worried about parts of sub-Saharan Africa.
Reporting by Raghav Mahobe in Bengaluru and Jennifer Rigby in London; Editing by Maju Samuel
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NEW YORK, Oct 20 (Reuters) – Pfizer Inc expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the United States government’s current purchase program expires, Pfizer executive Angela Lukin said on Thursday.
Lukin said she expects the vaccine – currently provided for free to all by the government – will be made available at no cost to people who have private insurance or government paid insurance.
Reuters earlier on Thursday reported that Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant vaccine makers would need to hike prices to meet revenue forecasts for 2023 and beyond.
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The U.S. government currently pays around $30 per dose to Pfizer and German partner BioNTech SE (22UAy.DE). In 2023, the market is expected to move to private insurance after the U.S. public health emergency expires.
“We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost effectiveness and ensures the price will not be a barrier for access for patients,” Lukin said.
It is not yet clear what kind of access people without health insurance will have to the vaccine.
Pfizer said it expects the COVID-19 market to be about the size of the flu shot market on an annual basis for adults, but that the pediatric market would take longer to build based on shots given so far.
So far the U.S. rollout of updated COVID-19 booster shots which target both the original coronavirus strain and the Omicron strain has lagged last year’s rate despite more people being eligible for the shots.
Around 14.8 million people in the U.S. received a booster shot over the first six weeks of the rollout of the new shots. In the first six weeks of the 2021 revaccination campaign, over 22 million people received their third shot even though only older and immunocompromised people were eligible at that point.
Lukin said she does not expect purchasing of the vaccines to transfer to the private sector until the first quarter of 2023 “at the earliest.” The move is dependent on the government contracted supply being depleted.
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Reporting by Michael Erman; Writing by Caroline Humer; Editing by Bill Berkrot and Richard Pullin
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CHICAGO, Oct 18 (Reuters) – Lauren Nichols, a 34-year-old logistics expert for the U.S. Department of Transportation in Boston, has been suffering from impaired thinking and focus, fatigue, seizures, headache and pain since her COVID-19 infection in the spring of 2020.
Last June, her doctor suggested low doses of naltrexone, a generic drug typically used to treat alcohol and opioid addiction.
After more than two years of living in “a thick, foggy cloud,” she said, “I can actually think clearly.”
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Researchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection.
The drug has been used with some success to treat a similar complex, post-infectious syndrome marked by cognitive deficits and overwhelming fatigue called myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Drawing on its use in ME/CFS and a handful of long COVID pilot studies, there are now at least four clinical trials planned to test naltrexone in hundreds of patients with long COVID, according to a Reuters review of Clinicaltrials.gov and interviews with 12 ME/CFS and long COVID researchers.
It is also on the short list of treatments to be tested in the U.S. National Institutes of Health’s $1 billion RECOVER Initiative, which aims to uncover underlying causes and find treatments for long COVID, advisers to the trial told Reuters.
Unlike treatments aimed at addressing specific symptoms caused by COVID damage to organs, such as the lungs, low-dose naltrexone (LDN) may reverse some of the underlying pathology driving symptoms, they said.
Naltrexone has anti-inflammatory properties and has been used at low doses for years to treat conditions such as fibromyalgia, Crohn’s disease and multiple sclerosis, said Dr. Jarred Younger, director of the Neuro-inflammation, Pain and Fatigue Laboratory at the University of Alabama at Birmingham.
At 50 milligrams – 10 times the low dose – naltrexone is approved to treat opioid and alcohol addiction. Several generic manufacturers sell 50mg pills, but low-dose naltrexone must be purchased through a compounding pharmacy.
Younger, author of a scientific review of the drug as a novel anti-inflammatory, in September submitted a grant application to study LDN for long COVID. “It should be at the top of everyone’s list for clinical trials,” he said.
Still, the drug is unlikely to help all patients with long COVID, a collection of some 200 symptoms ranging from pain and heart palpitations to insomnia and cognitive impairment. One 218-patient ME/CFS study found 74% had improvements in sleep, reduced pain and neurological disturbances.
“It’s not a panacea,” said Jaime Seltzer, a Stanford researcher and head of scientific outreach for the advocacy group MEAction. “These people weren’t cured, but they were helped.”
‘HUMAN AGAIN’ Dr. Jack Lambert, an infectious disease expert at University College Dublin School of Medicine, had used LDN to treat pain and fatigue associated with chronic Lyme disease.
During the pandemic, Lambert recommended LDN to colleagues treating patients with lingering symptoms after bouts of COVID.
It worked so well that he ran a pilot study among 38 long COVID patients. They reported improvements in energy, pain, concentration, insomnia and overall recovery from COVID-19 after two months, according to findings published in July.
Lambert, who is planning a larger trial to confirm those results, said he believes LDN may repair damage of the disease rather than mask its symptoms.
Other planned LDN trials include one by the University of British Columbia in Vancouver and a pilot study by Ann Arbor, Michigan-based startup AgelessRx. That study of 36 volunteers should have results by year-end, said company co-founder Sajad Zalzala.
Scientists are still working on explaining the mechanism for how LDN might work.
Experiments by Dr. Sonya Marshall-Gradisnik of the National Centre for Neuroimmunology and Emerging Diseases in Australia suggest ME/CFS and long COVID symptoms arise from a significant reduction in function of natural killer cells in the immune system. In laboratory experiments, LDN may have helped restore their normal function, a theory that must still be confirmed.
Others believe infections trigger immune cells in the central nervous system called microglia to produce cytokines, inflammatory molecules that cause fatigue and other symptoms associated with ME/CFS and long COVID. Younger believes naltrexone calms these hypersensitized immune cells.
Dr. Zach Porterfield, a virologist at the University of Kentucky who co-chairs a RECOVER task force looking at commonalities with other post-infectious syndromes, said it has recommended LDN be included in RECOVER’s treatment trials.
Other therapies under consideration, sources said, were antivirals, such as Pfizer Inc’s (PFE.N) Paxlovid, anti-clotting agents, steroids and nutritional supplements. RECOVER officials said they have received dozens of proposals and could not comment on which drugs will be tested until trials are finalized.
Dr. Hector Bonilla, co-director of the Stanford Post-Acute COVID-19 Clinic and a RECOVER adviser, has used LDN in 500 ME/CFS patients, with about half reporting benefits.
He studied LDN in 18 long COVID patients, with 11 showing improvements, and said he believes larger, formal trials could determine whether LDN offers a true benefit.
Nichols, a patient adviser to RECOVER, was “ecstatic” when she learned LDN was being considered for the government-funded trials.
While LDN has not fixed all her COVID-related problems, Nichols can now work all day without breaks and have a social life at home.
“It has made me feel like a human again.”
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Reporting by Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot
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Oct 6 (Reuters) – A rebound of COVID-19 symptoms in some patients after taking Pfizer’s antiviral Paxlovid may be related to a robust immune response rather than a weak one, U.S. government researchers reported on Thursday.
They concluded that taking a longer course of the drug – beyond the recommended five days – was not required to reduce the risk of a recurrence of symptoms as some have suggested, based on an intensive investigation of rebound in eight patients at the National Institutes of Health’s Clinical Center.
All patients in the study had developed robust immune responses, but researchers found higher levels of antibodies in the patients who experienced a rebound.
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The team said their data argues against the hypothesis that impaired immune responses are the reason symptoms return in some patients.
“Our findings suggest that a more robust immune response rather than uncontrolled viral replication characterizes these clinical rebounds,” the team wrote.
The study, published in the journal Clinical Infectious Diseases, followed numerous reports of individuals who took Paxlovid as recommended within five days of infection and saw a return of symptoms after they completed the five-day course of treatment.
President Joe Biden and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci both experienced a COVID rebound after taking the medicine.
The cases raised concerns that Pfizer’s two-drug antiviral treatment could interfere with development of a long-lasting immune response.
The study involved six people whose COVID symptoms returned after taking Paxlovid, and two with rebound symptoms after apparent recovery who did not take the pills. Their responses were compared to a group of six people who had COVID but did not experience a rebound. All volunteers had been vaccinated and boosted and all were infected with some version of the Omicron variant of the virus.
Blood from study volunteers underwent intensive investigation to assess their immune response during the acute infection phase and the rebound phase.
All of the rebound patients had experienced significant improvement in their symptoms before their rebound. Of those who had a rebound after Paxlovid, four had milder symptoms than during their initial infection, one had the same level of severity and one reported worse symptoms.
None of the rebound patients required additional treatment or hospitalization.
Rebound symptoms may be partially driven by a robust immune response to residual virus in the respiratory tract, the study authors suggested. They concluded that the drug does not impede the immune response in some individuals, as some had feared.
Larger and more detailed studies are needed to further understand COVID symptom rebound, the research team said, adding that the current data supports the need for isolation of such patients.
The researchers also suggested that there is still a need to evaluate longer courses of Paxlovid in immunocompromised individuals where the immune response may be ineffective.
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Reporting by Leroy Leo in Bengaluru and Julie Steenhuysen in Chicago; Editing by Bill Berkrot
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Sept 27 (Reuters) – Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) on Tuesday said their experimental Alzheimer’s drug significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, marking a rare win in a field littered with failed drugs.
The drug, lecanemab, slowed progress of the brain-wasting disease by 27% compared with a placebo, meeting the study’s main goal, and potentially offering hope for patients and their families desperate for an effective treatment.
“It’s not a huge effect, but it’s a positive effect,” said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center in Rochester, Minnesota.
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Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval under an accelerated pathway, with a decision expected in early January. On Tuesday the Japanese drugmaker said it will use the new efficacy results to submit lecanemab for traditional FDA review as well.
The company said it will also seek authorization in Japan and Europe during its current fiscal year, ending March 31.
Eisai said results from the 1,800-patient trial prove the longstanding theory that removal of sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can delay advance of the debilitating disease.
“This means that treating amyloid is a step in the right direction,” Petersen said.
Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer’s drug, rose as much as 6.7% in after hours trade.
The lecanemab data suggest “a potentially new multi-billion dollar franchise,” Jefferies analyst Michael Yee said in a research note.
Lecanemab, like the partners’ previous drug Aduhelm, is an intravenous antibody designed to remove amyloid deposits. Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together.
“If you can slow a disease by almost 30% that’s fantastic. This is what we have been looking for,” said Dr. Jeff Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada Las Vegas.
The so-called amyloid hypothesis has been challenged by some scientists, particularly after the U.S. Food and Drug Administration’s controversial approval of Aduhelm in 2021 based on its plaque-clearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA’s own panel of outside experts had advised against approval.
Aduhelm was the first new Alzheimer’s drug approved in 20 years after a long list of high-profile failures for the industry. read more
Patient advocacy groups hailed the news of positive lecanemab trial results.
“This is important because it demonstrates that each of these drugs is different … I would hope that the FDA approves the drug in January,” USAgainstAlzheimer’s Chairman George Vradenburg told Reuters.
The Phase III trial evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment and problem solving and personal care.
BRAIN SWELLING
The rate of a brain swelling side effect associated with anti-amyloid treatments was 12.5% in the lecanemab group, versus 1.7% in the placebo group. But many cases did not cause symptoms, with symptomatic brain swelling seen in 2.8% of those in the lecanemab group, the companies said.
Micro hemorrhages in the brain occurred at a rate of 17% in the lecanemab group, and 8.7% in the placebo group.
Petersen said the side effect rate was much less than with Aduhelm and “certainly tolerable.”
Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost.
The controversy and reluctance by some payers to cover Aduhelm led Biogen to slash the drug’s price to $28,000 per year from an initial $56,000.
But Medicare, the U.S. government health plan for people 65 and older, this year said it would only pay for Aduhelm and other similar drugs if patients were enrolled in a valid clinical trial, which sharply curtailed the medication’s use. Since Alzheimer’s is a disease of aging, an estimated 85% of patients eligible for the drug are covered by the government plan.
Michael Irizarry, Eisai’s deputy chief clinical officer, said on a conference call that the company will have discussions with the Medicare agency regarding coverage of lecanemab.
The number of Americans living with Alzheimer’s is expected to rise to around 13 million by 2050 from more than 6 million currently, according to the Alzheimer’s Association. Globally, that figure could rise to 139 million by 2050 without an effective treatment, according to Alzheimer’s Disease International.
Other plaque-targeting antibodies in late-stage development for Alzheimer’s patients include Roche Holding AG’s (ROG.S) gantenerumab and Eli Lilly’s donanemab.
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Reporting by Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Bill Berkrot and Richard Pullin
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Sept 14 (Reuters) – The world has never been in a better position to end the COVID-19 pandemic, the head of the World Health Organization said on Wednesday, his most optimistic outlook yet on the years-long health crisis which has killed over six million people.
“We are not there yet. But the end is in sight,” WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a virtual press conference.
That was the most upbeat assessment from the UN agency since it declared an international emergency in January 2020 and started describing COVID-19 as a pandemic three months later.
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The virus, which emerged in China in late 2019, has killed nearly 6.5 million people and infected 606 million, roiling global economies and overwhelming healthcare systems.
The rollout of vaccines and therapies have helped to stem deaths and hospitalisations, and the Omicron variant which emerged late last year causes less severe disease. Deaths from COVID-19 last week were the lowest since March 2020, the U.N. agency reported.
Still on Wednesday, he again urged nations to maintain their vigilance and likened the pandemic to a marathon race.
“Now is the time to run harder and make sure we cross the line and reap the rewards of all our hard work.”
Countries need to take a hard look at their policies and strengthen them for COVID-19 and future viruses, Tedros said. He also urged nations to vaccinate 100% of their high-risk groups and keep testing for the virus.
The WHO said countries need to maintain adequate supplies of medical equipment and healthcare workers.
“We expect there to be future waves of infections, potentially at different time points throughout the world caused by different subvariants of Omicron or even different variants of concern,” said WHO’s senior epidemiologist Maria Van Kerkhove.
With over 1 million deaths this year alone, the pandemic remains an emergency globally and within most countries.
“The COVID-19 summer wave, driven by Omicron BA.4 and BA.5, showed that the pandemic is not yet over as the virus continues to circulate in Europe and beyond,” a European Commission spokesperson said.
WHO’s next meeting of experts to decide whether the pandemic still represents a public health emergency of international concern is due in October, a WHO spokesperson said.
GLOBAL EMERGENCY
“It’s probably fair to say most of the world is moving beyond the emergency phase of the pandemic response,” said Dr Michael Head, senior research fellow in global health at Southampton University.
Governments are now looking at how best to manage COVID as part of their routine healthcare and surveillance, he said.
Europe, the United Kingdom and the United States have approved vaccines that target the Omicron variant as well as the original virus as countries prepare to launch winter booster campaigns.
In the United States, COVID-19 was initially declared a public health emergency in January 2020, and that status has been renewed quarterly ever since.
The U.S. health department is set to renew it again in mid-October for what policy experts expect is the last time before it expires in January 2023.
U.S. health officials have said that the pandemic is not over, but that new bivalent vaccines mark an important shift in the fight against the virus. They predict that a single annual vaccine akin to the flu shot should provide a high degree of protection and return the country closer to normalcy.
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Reporting by Manas Mishra, Khushi Mandowara in Bengaluru, Ahmed Aboulenein in Washington and Jennifer Rigby in London; Editing by Shounak Dasgupta, William Maclean, Josephine Mason, Elaine Hardcastle
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