Novo Nordisk makes headway in bid to rule obesity market with stunning phase 3 semaglutide data

Novo Nordisk has taken one step forward in its ambition to move its Type 2 diabetes drug semaglutide into the giant and largely untapped obesity market. And despite the failure of past obesity drugs—not to mention lackluster sales of Novo’s own weight loss product Saxenda—the company’s executives now have even more reason to be optimistic.

Data from a phase 3 trial released Wednesday night showed that one-third of patients taking semaglutide, a GLP-1 agonist, lost more than 20% of their body weight during the 68-week trial. The average participant lost more than 33 pounds, and many saw improvements in risk factors for diabetes and heart disease, according to University College London, one of the principle trial sites. The study was published in the New England Journal of Medicine.

“No other drug has come close to producing this level of weight loss—this really is a game-changer,” study co-author Rachel Batterham, a professor of diabetes, obesity and endocrinology at University College London, said in a statement.

Novo Nordisk applied to the FDA for approval of semaglutide in obesity in December and used a priority voucher it had acquired to speed up the review time. Mads Thomsen, Novo’s head of R&D, said during Novo’s fourth-quarter conference call last week that the company expects a verdict from the FDA as soon as mid-year and a decision in Europe by early 2022.

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The weight-loss study enrolled 1,961 adults in 16 countries who were randomized to receive either a placebo or a 2.4 mg dose of semaglutide by self-injection once a week—more than double the dose that’s typically prescribed for diabetes, where the drug carries the brand name Ozempic. All the participants in the trial received counseling focused on improving their diet and exercise habits.

Two physicians who wrote an editorial accompanying the semaglutide study said they were encouraged by the results, but they also voiced a few caveats. The drug can cause gastrointestinal distress, and the trial’s relatively short length made it impossible to judge long-term efficacy—an obstacle “since obesity is a chronic problem requiring constant attention,” wrote Julie Ingelfinger, M.D., of Tufts University School of Medicine and Clifford Rosen, M.D., of Maine Medical Center Research Institute. They also noted that the majority of the trial participants were women and that minorities were underrepresented.

No doubt marketing semaglutide will be a challenge for Novo Nordisk, especially if COVID restrictions are still in place when it launches. Sales of its obesity drug Saxenda grew just 3% last year, even though the company owns an estimated 80% of the market for prescription obesity drugs.

During the earnings call, CEO Lars Jørgensen said obesity sales had suffered because the pandemic was causing fewer patients to seek out medical treatments for weight loss. But the company has encountered some obstacles with reimbursement, too. Last year, the U.K.'s National Institute for Health and Care Excellence (NICE) initially rejected Saxenda for coverage there, citing a lack of long-term efficacy data. In December it updated the guidance to recommend the treatment, but only for patients who met a long list of criteria that included a high risk of cardiovascular disease. Novo had to provide the drug at a discount, which was not disclosed.

RELATED: Novo Nordisk, following in Lilly's Trulicity footsteps, files higher Ozempic dose for diabetes

The filing for approval of semaglutide for obesity is part of a larger development plan for the drug. In January, Novo Nordisk filed for FDA approval of a 2.0 mg dose of Ozempic in diabetes, part of a bid to catch up to Eli Lilly’s GLP-1 drug Trulicity. Both drugs have proven in trials to be more effective at reducing blood sugar at higher doses. And Novo’s oral version of semaglutide, Rybelsus, continues to grab share, particularly among diabetes patients who are new to the GLP-1 market.

But obesity could be an even bigger opportunity, given the dearth of prescription drugs that are meaningfully effective, Novo Nordisk executives contend.

During the earnings call, Camilla Sylvest, the company’s head of commercial strategy and corporate affairs, noted that semaglutide has been shown to be almost twice as effective as Saxenda. What’s more, she said, only 10% of the estimated 650 million people with obesity are seeking weight-loss remedies. “So there's still a lot to do on market development in the coming six months. And hopefully, that will also pave the way for a much more efficacious product in semaglutide,” she said.