• Staff

Novo’s Semaglutide Won its Coveted FDA Green Light to Treat Obesity

With obesity prevalent, undertreated, and hugely misunderstood, Novo Nordisk has been attempting to revolutionize the field with semaglutide, a medication originally approved to treat diabetes. Last Friday, the company won its highly coveted FDA approval in obesity.

Named Wegovy, the drug has been subjected to FDA review since December – a swift trip through the agency, thanks to a priority review voucher that pushed the process into high gear.

With this “game-changer” approval, Novo is ready to disrupt the massive and hugely untapped obesity niche, where patients have for long craved for abundant attractive treatment options.

To assert its influence, the company notes three major hurdles it will have to overcome, Doug Langa, executive vice president for North America, disclosed in an interview.

First, “we need more patients to seek treatment,” Langa noted. There is a “real stigma and bias” around obesity, he said. “We’ve got to break those walls down.”

It’s crucial to reaffirm to patients living with obesity that “it’s not their fault, and that it’s not just about eating less and moving more,” he noted.

“There is a medical adaptation that they need to understand like any other serious disease.”

To woo more doctors into having those conversations with patients, the company has launched an unbranded, physician awareness website, Rethink Obesity, with the aim to help doctors “recognize, understand, diagnose and treat” the disease, Novo’s director of media relations, Michael Bachner, affirmed during the interview.

The last piece of the puzzle will be access and reimbursement, Langa noted. Novo is keeping launch specifics discreet at the moment, but it has “big promotional plans” for Wegovy, he explained.

The FDA approved the drug, as a complementary to diet and exercise, premised on phase 3 data confirming Wegovy assisted one-third of patients to lose more than 20% of their body weight over the 68-week trial period. Patients free from type 2 diabetes lost 17% to 18% of their weight on average.

Obesity is a “gateway disease into 60 other health conditions,” Langa explained. Novo’s other approved weight loss drug, Saxenda, assists patients to lose approximately 5% of their body weight on average. That’s already clinically significant, Langa noted, but with impressive weight loss figures, Wegovy has shown, “we’re seeing significant signs of improvements in cardiovascular disease, as well as heart failure,” in addition to reduced type 2 diabetes.

For now, Wegovy looks set to dominate the obesity niche, though it could eventually face rivalry from Eli Lilly’s dual GIP/GLP-1 agonist tirzepatide.