Novo’s Wegovy Approved After Superior Weight-Loss Impact Shown
Novo Nordisk’s Weight Loss Injection Receives FDA Approval
(Bloomberg) -- Novo Nordisk A/S gained U.S. approval for its therapy that helped patients lose about 15% of their body weight on average in trials, an alternative to an existing treatment from the Danish drugmaker as well as invasive, costly obesity surgery.
The drug, called Wegovy, will be available to obese adults and certain overweight people and should be used in conjunction with diet and exercise, Novo Nordisk said in a statement. About three-quarters of Americans are overweight or obese.
The drug’s clinical impact is “a game-changer because we’re getting into double digits,” said Ethan Lazarus, president-elect of the Obesity Medicine Association and a recipient of speaking fees from Novo Nordisk, in an interview. Available therapies, including another Novo product called Saxenda, reduce weight by about 5% to 10%.
Wegovy is the first weight management drug approved for chronic use in most obese and overweight adults in several years, the FDA said Friday in a statement. The medication will carry a warning about risk of a certain thyroid cancer.
It may face an uphill battle, in large part because of skepticism from patients, doctors and health insurers about the efficacy and safety of obesity drugs. Wegovy, which will be available in pharmacies by the end of June, may address some of those issues. Like Saxenda, it’s part of a class of drugs known as GLP-1 receptor agonists that bind and activate brain proteins involved in regulating appetite, making patients feel full and eat less.
Complex Factors
“The results speak for themselves, and we’re definitely going to utilize that,” said Doug Langa, president of Novo’s U.S. business, in an interview before the approval was announced. The company hasn’t forecast sales for Wegovy this year, but it believes that the new drug could become a blockbuster over time, Langa said.
Wegovy’s price will be similar to Saxenda, which is $1,349 a month, Novo spokesman Michael Bachner said. The company plans to make the exact cost available in the coming days.
The American Medical Association recognized obesity as a disease in 2013. Research has shown the condition is influenced by a complex array of biological factors that limit the impact of diet and exercise.
Yet despite the availability of some FDA-approved weight loss drugs, their use has been limited. That’s due to a combination of factors, from only modest efficacy to date to stigma, a lack of training for doctors and low levels of insurance coverage. In addition, a history of unsafe weight loss drugs has left patients and medical providers wary.
Physician Familiarity
Other GLP-1 drugs for diabetes have sold for more than a decade, lending physicians familiarity and comfort with safety. Semaglutide, Wegovy’s main active ingredient, is included in Novo Nordisk’s diabetes medications Ozempic and Rybelsus.
In four late-stage clinical trials, most patients taking Wegovy alongside interventions like diet and exercise lost at least 5% of their body weight, with an average reduction of about 15%. The results were published in peer-reviewed journals including the New England Journal of Medicine and the Journal of the American Medical Association.
About half the patients in the research trials lost more than 15% of their body weight, “something that we haven’t seen before,” said Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine. “It looks like some of the barriers to weight loss -- it may be possible to overcome them.”
Aronne receives research funds from Novo Nordisk, and serves as a consultant as well as on an advisory board for the company.
Trial participants took the weekly, self-injected drug for just over a year. Results from another trial lasting two years haven’t yet been reported. Gastrointestinal side effects like nausea and diarrhea were common adverse events.
Insurance Coverage
David Scheesley, a 42-year-old corrections officer from Hanford, California said he has struggled with his weight for many years, trying numerous diets that were often initially successful but not in the long term. He participated in the trial after his cardiologist diagnosed him with high blood pressure and encouraged him to lose weight.
Wegovy was the first weight-loss drug he had ever taken. Scheesley quickly lost 20 pounds in the first two months, and his blood pressure fell to a normal range. All told he lost about 50 pounds, some of which he gained back after the trial ended. Scheesley said he hopes to start taking Wegovy again when it’s available.
Novo Nordisk is looking to see if there are trends among responders to Wegovy that could help doctors match the drug to specific patients, though it hasn’t observed any yet, said Jason Brett, executive director of medical affairs for Novo’s U.S. business, in an interview.
Getting access to the new drug is also likely to be fraught for patients, noted Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston. Apovian serves on Novo Nordisk’s scientific advisory board.
“Obesity drugs have difficulty getting insurance coverage, because we don’t see obesity as a disease,” she said.
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