With obesity widespread, undertreated and largely misunderstood, Novo Nordisk has been gunning to overhaul the field with semaglutide, a drug originally approved to treat diabetes. On Friday, it won its coveted FDA green light in obesity.
Now christened Wegovy, the drug has been under FDA review just since December—a speedy trip through the agency, thanks to a priority review voucher that kicked the process into high gear.
Armed with this "game changer" approval, Novo is set to disrupt the massive and largely untapped obesity market, where patients have long suffered from few attractive treatment options.
To make its mark, the company sees three major challenges it will need to overcome, Doug Langa, executive vice president for North America, said in an interview.
First, "we need more patients to seek treatment," Langa said. There's a "real stigma and bias" around obesity, he said. "We've got to break those walls down."
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It's crucial to help patients living with obesity understand that "it's not their fault, and that it's not just about eating less and moving more," he said. "There's a medical adaptation that they need to understand like any other serious disease."
To persuade more doctors to have those discussions with patients, the company has rolled out an unbranded, physician awareness website, Rethink Obesity, aiming to help doctors "recognize, understand, diagnose and treat" the disease, Novo's director of media relations, Michael Bachner, said during the interview.
The final piece of the puzzle will be access and reimbursement, Langa said. Novo is keeping launch specifics close to the vest for now, but it has "big promotional plans" for Wegovy, he said. In early May, he told Fierce Pharma the company had “been laying the groundwork” for its obesity rollout and had already started working with payers where possible.
The FDA approved the drug, as an addition to diet and exercise, based on phase 3 data showing Wegovy helped one-third of patients lose more than 20% of their body weight over the 68-week trial period. Patients without type 2 diabetes lost 17% to 18% of their weight on average.
Obesity is a "gateway disease into 60 other health conditions," Langa said. Novo's other approved weight loss drug, Saxenda, helps patients lose around 5% of their body weight on average. That's already clinically meaningful, Langa said, but with the impressive weight loss figures Wegovy has demonstrated, "we're seeing significant signs of improvements in cardiovascular disease, as well as heart failure," plus reduction in type 2 diabetes.
On that front, Novo is recruiting for its Select study, which aims to determine whether the medicine can cut cardiovascular risks in overweight patients with CV disease. The event-based trial is projected to read out by the end of 2023, Bachner said over email.
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For now, Wegovy looks poised to dominate the obesity market, though it could eventually face competition from Eli Lilly's dual GIP/GLP-1 agonist tirzepatide. Lilly is testing the drug in type 2 diabetes, and in a recent head-to-head with injectable semaglutide 1 mg—a lower dose than Wegovy's 2.4 mg—the new drug delivered better weight loss outcomes.
Having other new drugs in the obesity field wouldn't necessarily be a bad thing, Langa said. If other companies emerge with effective obesity treatments, they'll need to work the same market development angles, Langa said "bringing more attention" to the field. That could help patients and doctors better understand obesity as a disease, as well as the treatment options available.
Friday's approval covers injectable semaglutide, but Novo already has its sights set on more convenient dosing in the future. In the second half of 2021, Novo aims to enroll about 1,000 patients for a phase 3a trial testing the safety and efficacy of oral semaglutide 50 mg versus placebo in overweight or obese patients with comorbidities.