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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WASHINGTON, Dec 29 (Reuters) – The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s (BIIB.O) Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.
The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug’s regulatory review, approval, pricing, and marketing.
The FDA approved Aduhelm in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug’s benefit to patients.
It was authorized based on evidence that it could reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slowed progression of the lethal mind-wasting disease.
The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug.
Biogen set an “unjustifiably high” price by initially setting Aduhelm’s price at $56,000 per year despite a lack of demonstrated clinical benefit in a broad patient population, the report said, adding that the company’s own internal projections showed it expected the drug to be a burden to Medicare and costly to patients.
“The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the report, prepared by the staffs of the House Committee on Oversight and Reform and House Committee on Energy and Commerce, concluded.
The agency should ensure that all substantive interactions with drug sponsors are properly memorialized, establish a protocol for joint briefing documents with drug sponsors, and update its industry guidance on the developments and review of new Alzheimer’s Drugs, the report recommended.
Biogen and other drugmakers should communicate to the FDA any concerns over safety and efficacy to the FDA as well as take value and patient access into consideration when setting prices, the report said.
An FDA spokesperson said the FDA’s decision to approve Aduhelm was based on scientific evaluation of the data contained in the application.
He pointed to the FDA’s internal review finding its staff’s interactions with Biogen appropriate.
“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients,” he said, adding that the agency will continue to use the accelerated approval pathway whenever appropriate.
The FDA has already begun implementing some of the report’s recommendations, the spokesperson said.
“Biogen stands by the integrity of the actions we have taken,” the Cambridge, Mass.-based biotech company said in an emailed statement.
“As stated in the congressional report, an (FDA) review concluded that, ‘There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'” Biogen said.
Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.
The total number of meetings is unknown because the FDA failed to keep a clear record of informal meetings and interactions between its staff and Biogen representatives. The investigation identified an additional 66 calls and email exchanges that were not memorialized.
The FDA inappropriately collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System (PCNS) Advisory Committee, the report said, with FDA and Biogen staff working closely for months ahead of the Nov. 6, 2020 meeting to prepare the document, which failed to adequately represent differing views within the agency.
“Using a joint briefing document afforded Biogen advance insight into FDA’s responses and direct guidance from the agency in drafting the company’s own sections. For example, in an exchange of the draft briefing document on October 9, 2020, FDA staff asked Biogen to move a paragraph drafted by the agency into Biogen’s section of the memorandum—a change reflected when the document was finalized,” the report made public to media organizations said.
When none of the advisory panel members voted to approve Aduhelm, the FDA pivoted to using its accelerated approval pathway – typically used for rare diseases or small patient populations that lack access to effective treatments – despite having considered the drug under the traditional approval pathway for nine months, the report said.
It did so on a substantially abbreviated timeline, approving it after three weeks of review, and for a broad label indication of “people with Alzheimer’s disease” that was unsupported by clinical data, the report said.
Internal documents obtained by the investigation showed that Biogen accepted the indication despite its own reservations over the lack of evidence Aduhelm could help patients at disease stages outside of its clinical trials.
Reporting by Ahmed Aboulenein; editing by Diane Craft
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Ahmed Aboulenein
Thomson Reuters
Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.
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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IRVINE, Calif., Oct 14 (Reuters) – U.S. President Joe Biden criticized Republicans and drug companies during a stop at a California community college on Friday as he campaigned for fellow Democrats in November’s midterm elections.
Biden’s trip includes stops in California on Friday and Oregon on Saturday as the president looks to position his party, the Democrats, as a champion of consumers and lower healthcare costs at a time that inflation ranks among voters’ top concerns. The midterm elections are on Nov. 8.
“We took on Big Pharma and we beat them, finally,” Biden said, referring to the recently passed Inflation Reduction Act’s provisions allowing Medicare to negotiate lower drug prices, caps the cost senior citizens are charged for prescriptions and lowers insulin prescriptions to $35 for Medicare beneficiaries.
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Biden promised to cap the insulin price at $35 for all Americans if Democrats keep the House and Senate. Most forecasts show Democrats with a slight advantage in the Senate and Republicans with a larger advantage in the House.
He claimed that Republicans will repeal the prescription drug price caps and take away Medicare’s ability to negotiate drug prices if they take control.
Biden’s motorcade was greeted in Irvine by more than 1,000 raucous protesters calling for Democracy in Iran, where anti-government demonstrations have raged for several weeks.
The president made reference to the protests in his remarks, saying that the United States stood with the Iranian people.
“He was moved by the protests that he saw from … Iranian Americans who were there,” White House spokeswoman Karine Jean-Pierre said later. “It struck him and he wanted to comment about that at the top.”
The president was introduced by Democratic Representative Katie Porter, who has grilled bank and drug company executives on their profits in widely viewed Congressional hearings.
“Here’s the stone cold truth. Corporate greed worsens health outcomes, rips off taxpayers and threatens our capitalist economy,” Porter said, accusing the pharmaceutical industry of crushing competition and price transparency.
Biden signed an order Friday requiring the U.S. Department of Health & Human Services (HHS) to outline within 90 days how it will use new models of care and payment to cut drug costs.
Data on Thursday showed U.S. consumer prices jumped 8.2% in the 12 months through September, after peaking above 9% in the summer and growing at their fastest pace since 1981. Healthcare costs were partly to blame in the most recent month, along with food and rent.
HHS was given the power to promote new approaches to lowering costs and widening care through an Innovation Center, created by a 2010 healthcare reform law known as Obamacare and housed at the Centers for Medicare and Medicaid Services.
Some 65 million Americans are enrolled in Medicare programs, which have repeatedly come under fire for its cost to taxpayers.
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Reporting by Trevor Hunnicutt and Jeff Mason; Additional reporting by Dan Whitcomb; Editing by Heather Timmons, David Gregorio & Shri Navaratnam
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Oct 11 (Reuters) – The U.S. Supreme Court on Tuesday declined to decide whether fetuses are entitled to constitutional rights in light of its June ruling overturning the 1973 Roe v. Wade decision that had legalized abortion nationwide, steering clear for now of another front in America’s culture wars.
The justices turned away an appeal by a Catholic group and two women of a lower court’s ruling against their challenge to a 2019 Rhode Island law that codified the right to abortion in line with the Roe precedent. The two women, pregnant at the time when the case was filed, sued on behalf of their fetuses and later gave birth. The Rhode Island Supreme Court decided that fetuses lacked the proper legal standing to bring the suit.
Rhode Island Governor Daniel McKee, a Democrat, welcomed Tuesday’s action by the justices.
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“We’re satisfied that the Supreme Court declined to hear this frivolous appeal. Governor McKee believes that we should be expanding access to reproductive healthcare for women,” spokesperson Matt Sheaff said in a statement, adding that the governor “is committed to using his veto pen to block any legislation that would take our state backwards.”
Lawyers representing the plaintiffs did not respond to requests for comment.
Conservative Justice Samuel Alito wrote in June’s ruling overturning the abortion rights precedent that in the decision the court took no position on “if and when prenatal life is entitled to any of the rights enjoyed after birth.”
Some Republicans at the state level have pursued what are called fetal personhood laws, like one enacted in Georgia affecting fetuses starting at around six weeks of pregnancy, that would grant fetuses before birth a variety of legal rights and protections like those of any person.
Under such laws, termination of a pregnancy legally could be considered murder.
Lawyers for the group Catholics for Life and the two Rhode Island women – one named Nichole Leigh Rowley and the other using the pseudonym Jane Doe – argued that the case “presents the opportunity for this court to meet that inevitable question head on” by deciding if fetuses possess due process and equal protection rights conferred by the U.S. Constitution’s 14th Amendment.
The Rhode Island Supreme Court relied on the now-reversed Roe precedent in finding that the 14th Amendment did not extend rights to fetuses. The Roe ruling had recognized that the right to personal privacy under the U.S. Constitution protected a woman’s ability to terminate her pregnancy.
Old Rhode Island laws included a criminal statute, predating the Roe ruling, that had prohibited abortions. After the Roe ruling, a federal court declared that Rhode Island law unconstitutional, and it was not in effect when the Democratic-led legislature enacted the 2019 Reproductive Privacy Act.
Gina Raimondo, a Democrat who was the state’s governor at the time and is now President Joe Biden’s U.S. commerce secretary, signed the 2019 law, which codified the then-status quo under Roe in terms of abortion rights.
More than a dozen states have enforced near-total abortion bans since the Supreme Court’s abortion June ruling in a case called Dobbs v. Jackson Women’s Health Organization.
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Reporting by Nate Raymond in Boston; Editing by Will Dunham
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Thomson Reuters
Nate Raymond reports on the federal judiciary and litigation. He can be reached at nate.raymond@thomsonreuters.com.
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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