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Why You Can’t Find Wegovy, the Weight-Loss Drug

Novo Nordisk

NVO 0.61%

A/S flubbed the launch of its buzzy new weight-loss drug Wegovy, missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product.

Wegovy is among a new class of drugs that health regulators have approved to cut the weight of people who are obese, a goal long sought by doctors and patients. Their weight-dropping potential became a viral sensation on social media. Elon Musk tweeted about Wegovy in October. And a related drug for diabetes, Ozempic, is a hot topic in Hollywood among celebrities seeking to stay thin, according to doctors.

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Yet Denmark-based Novo underestimated how big demand for the drug would be, and wasn’t ready to make enough to fill the prescriptions that flooded in after U.S. approval last year. Then a contract manufacturer halted production to address inspection issues.

“We should have forecasted better, which we did not,” Novo Chief Executive

Lars Fruergaard Jørgensen

said. “Had we forecasted that, we would have built a different supply chain.”

The missteps have proven costly for Novo, which was forced to ration Wegovy to patients who already had started taking it. The company has recorded around $700 million in sales to date, well short of the $2 billion in 2021 and 2022 sales that some analysts had projected before supply issues hit.

Novo Nordisk Chief Executive Lars Fruergaard Jørgensen admits the drug company misjudged how popular Wegovy would be.



Photo:

Carsten Snejbjerg/Bloomberg News

Amber Blaylock, a music teacher from Springfield, Mo., said she has been trying to get Wegovy to help her reduce weight since hearing about the drug on TikTok and YouTube. She asked her doctor in September to prescribe it, but hasn’t been able to find it. 

“Frustrated and impatient for sure,” said Ms. Blaylock, 29 years old.

To turn things around, Mr. Jørgensen said Novo has increased its capacity to make Wegovy and plans a “relaunch” early next year, which should fulfill all orders.

Novo, however, lost valuable time establishing a beachhead in the lucrative obesity-drug market before rival

Eli Lilly

LLY 1.20%

& Co. can enter. Lilly is expected to launch a similar, competing drug named Mounjaro late next year or in early 2024.

The market for anti-obesity drugs, now worth $2.4 billion worldwide, could reach $50 billion in 2030, Morgan Stanley estimates.

“Novo has left the door open for Lilly,” said BMO Capital Markets analyst Evan David Seigerman. 

Mr. Jørgensen said the company can regain lost ground because of high demand for Wegovy and the large potential for what is still a mostly untapped market. He said he was unconcerned with the looming competition with Lilly’s drug, because there is room for both products.

“We disappointed physicians and patients in the first round,” he said. “The company wants to be better prepared for the second round.” Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.  

Wegovy works by imitating a hormone called GLP-1, which occurs naturally in the body and suppresses appetite, among other effects. 

Novo developed GLP-1 drugs to treat diabetes. In 2017, the company began selling semaglutide, the active ingredient in Wegovy, under the brand name Ozempic to treat diabetes. 

During the drug’s development, Novo found that weight loss was a side effect, prompting the company to probe using semaglutide to treat obesity. A key trial found that Wegovy helped people with a high body-mass index shed up to 15% of their weight, surpassing the results for older obesity drugs like Novo’s Saxenda. 

Saxenda and other older weight-loss drugs had sold modestly, partly due to their limited weight loss, as well as some unpleasant side effects and the refusal of many health insurers to pay up. 

Novo worked with Catalent to fill its Wegovy weight-loss drug into syringes.



Photo:

yara nardi/Reuters

Given the experience, Novo figured Wegovy sales would increase gradually. To augment its own production, Novo contracted with a single manufacturer,

Catalent Inc.,

to fill the drug into syringes. Novo said it thought it would have time to add manufacturing capacity to meet a gradual increase in demand.

Wegovy may be superior to older drugs, but “we thought it would still be a journey to open up the market,” Mr. Jørgensen said. 

When Novo started selling Wegovy in the U.S. in June last year, however, demand took off. Doctors with large followings on social media touted Wegovy as groundbreaking, while users posted photos holding injection pens and shared their progress losing weight. 

“Demand for these new agents has been unlike anything I’ve ever seen in my time in medicine,” said Dr. Michael Albert, a physician specializing in weight-loss treatment at telehealth provider Accomplish Health who has consulted for Novo. Many of his patients began asking about Wegovy, he said, after they heard about it in Facebook groups or on TikTok.

It took only five weeks for doctors to write new prescriptions for Wegovy at the same weekly volume that Saxenda took four years to reach, according to Mr. Jørgensen. “It’s a completely different ballgame that we’re in,” said Ambre Brown Morley, the company’s vice president of media and digital global communication. 

Within weeks, supplies were strained. Novo warned that patients might experience delays in receiving their prescriptions. Then in December 2021, Catalent temporarily stopped deliveries and manufacturing at its plant after Food and Drug Administration inspections found faulty air filters and damaged equipment.

To date, Novo has recorded around $700 million in Wegovy sales compared with the $2 billion in 2021 and 2022 sales that some analysts had projected before supply issues emerged.



Photo:

JACOB GRONHOLT-PEDERSEN/REUTERS

Many people who couldn’t get Wegovy for weight loss have sought prescriptions for Novo’s Ozempic and Lilly’s Mounjaro, according to analysts, even though the FDA hasn’t approved the latter two drugs for such use. Ozempic sales increased so much that certain doses are in short supply through at least January, the FDA said.

Lilly is studying Mounjaro, its GLP-1-containing drug for diabetes, for weight loss. 

Novo and Lilly said they don’t promote their diabetes drugs for the “off-label” use treating obesity.

A Catalent spokesman said the company is still making improvements to the plant and working with customers to limit the impact of supply constraints on patients. The company restarted filling Wegovy syringes at the facility in the spring. 

Novo has been amassing a sufficient inventory before the Wegovy relaunch, Mr. Jørgensen said. When Wegovy relaunches, he said, insurance coverage will be broader than when the drug first went on sale. 

Write to Peter Loftus at Peter.Loftus@wsj.com and Denise Roland at denise.roland@wsj.com

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FDA Raises Concerns About China-Developed Drugs

U.S. regulators are poised to tap the brakes on approving dozens of cancer drugs and other new medicines developed in China.

The regulators have expressed concerns about the quality of studies largely conducted in China and whether the results can apply to patients in the U.S.

The shift threatens to halt the plans of Western drugmakers, including

Eli Lilly

LLY 1.40%

& Co. and

Novartis AG

NVS 0.06%

, who were eyeing billions of dollars in sales from bringing the Chinese medicines to the U.S. It could also raise a new source of tension between the two countries.

Lilly this year was aiming to roll out a lung-cancer immunotherapy developed in China and sell it at a lower price than similar drugs already on the market.

The Food and Drug Administration’s reservations threaten to upend the plans. The impact of its concerns could become clearer Thursday, when agency advisers consider the evidence for the drug from Lilly and its Chinese partner

Innovent Biologics Inc.

1801 2.48%

Eli Lilly is one of the Western drugmakers that have eyed sales from bringing Chinese drugs to the U.S.



Photo:

Mike Segar/REUTERS

The advisory committee is expected to vote on whether to recommend FDA approval of the drug and to discuss whether the Chinese clinical-trial results for it are applicable to American patients.

FDA officials say they are concerned about the quality of the studies evaluating China-developed drugs. The officials are also concerned the drugs haven’t been tested in U.S. patients.

“We have nothing against drugs being developed in China,” said Richard Pazdur, director of the FDA’s cancer-drugs division. “Our issue is, are those results generalizable to the U.S. population?”

Two Chinese drug-industry trade groups didn’t respond to requests for comment.

Drug-industry executives and analysts say the apparent shift in tone could lead to delays or outright FDA rejections of efforts to bring a growing pipeline of the treatments to American patients.

Chinese biotech companies and their Western partners may have to conduct additional tests of their proposed new drugs in U.S. patients, some analysts say.

“There does seem to be a change in tone as to the approvability of these data sets in the U.S.,” said

Jacob Van Naarden,

president of Lilly’s oncology unit. Innovent didn’t respond to requests for comment. The company said in a document submitted to the FDA that its study conducted in China supports approval.

China, long a source of drug ingredients, has placed a priority on developing a homegrown biotechnology industry in recent years.

In 2019, the FDA approved the drug, Brukinsa, a lymphoma treatment from

BeiGene Ltd.

, that had been primarily tested in China. Most subjects in the clinical studies that led to the approval were in China, but some were in the U.S.

That same year, Dr. Pazdur said at a medical conference the FDA would accept Chinese-only drug-study results if they were “quality” data.

Researchers work inside a Beijing laboratory at BeiGene, a Chinese biotechnology firm.



Photo:

Gilles Sabrie/Bloomberg News

Clinical trials, especially the large, late-stage studies that regulators review to decide whether to approve a new drug, are among the biggest research and development expenses.

Industry executives and analysts viewed Dr. Pazdur’s comments as offering a kind of shortcut for China-tested drugs to get cleared in the U.S. without having to do extensive U.S. trials.

“Now that path appears to be closing,” Bernstein analyst Ronny Gal said in an interview. He said Dr. Pazdur’s more recent comments amounted to “a clear change in tone at the FDA, from encouraging this to discouraging this.”

Dr. Pazdur said his 2019 comments have been misinterpreted as encouraging companies to take certain steps.

When drugs are tested only or primarily in one country such as China, Dr. Pazdur said, it is difficult to assess whether the drug would have the same benefits and safety profile in the U.S. population.

Richard Pazdur, director of the FDA’s cancer-drugs division, says he has concerns that the Chinese drug studies used outdated study designs.



Photo:

JOSHUA ROBERTS/BLOOMBERG NEWS

There may be differences between countries in medical care and population that affect how a drug performs, he said.

The FDA has more flexibility to accept China-only clinical data for diseases that are less common in the U.S. than in Asia., such as nasopharyngeal carcinoma, Dr. Pazdur said.

Dr. Pazdur said he was concerned the Chinese studies used outdated study designs, which don’t directly establish whether the China-developed drug works as well as similar drugs approved in the U.S. in recent years.

He also expressed concern about the integrity of data generated by drug studies in China.

An analysis by Chinese regulators in 2016 found that about 80% of domestic drug applications reviewed at that time contained fabricated, flawed or insufficient data from studies, the British Medical Journal has reported.

In some cases, there were discrepancies between original study data and what was submitted to regulators.

“The elephant in the room is obviously, what is the quality of the data that is coming from these foreign countries?” Dr. Pazdur said.

There are about 25 potential new cancer treatments that were tested only or predominantly in China and which companies have told the FDA they would like to sell in the U.S., Dr. Pazdur said.

FDA officials including Dr. Pazdur raised some of the concerns in an article published by the New England Journal of Medicine in December, titled “The Wild West of Checkpoint Inhibitor Development.”

Checkpoint inhibitors are cancer immunotherapies like the one that Lilly and partner Innovent want to bring to the U.S., named Tyvyt.

Lilly executives have said they would sell Tyvyt in the U.S. at a substantially lower price than older, similar drugs such as

Merck

& Co.’s Keytruda and

Bristol-Myers Squibb Co.

’s Opdivo. Lilly said Wednesday it would sell the drug at a 40% discount to comparable brands, pending regulatory approval.

Keytruda and Opdivo can cost more than $150,000 per patient annually.

Innovent conducted a trial of Tyvyt in nearly 50 hospitals in China that enrolled nearly 400 patients with advanced non-small-cell lung cancer.

Researchers found that giving patients both Tyvyt and chemotherapy prolonged the median time to disease progression or death to about 8.9 months, versus five months for those on chemotherapy alone.

Mr. Van Naarden said he thought the Tyvyt study was well-conducted and the results are applicable to the U.S. population.

FDA staff said, in a document posted online Tuesday, the data from the clinical trial “are not applicable to the U.S. population and U.S. medical practice.”

A final agency decision on whether to clear the Lilly-Innovent drug is expected by the end of March.

Write to Peter Loftus at peter.loftus@wsj.com

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