FDA decision on oral Wegovy coming in Q4

Novo Nordisk has pulled ahead in the race to bring the first oral GLP-1 for obesity to market. The company announced Friday that the FDA has accepted its New Drug Application (NDA) submission for a once-a-day 25mg pill form of Wegovy (semaglutide) for chronic weight management.

The FDA action date is in Q4 of this year according to the company, who also stated in a release that the submission is based on strong data from the Phase 3 OASIS study, some of which was shared at ADA in 2023.

"We are entering a new era of obesity care where patients want individualised treatment plans that address their needs and provide choices, including oral formulations," said Anna Windle, SVP of clinical development, medical, and regulatory affairs at Novo Nordisk, said in a statement. "Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment. We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity."

Semaglutide is already available in pill form under the name Rybelsus, but that drug, which cleared the FDA back in 2019, is only indicated for diabetes. While Rybelsus sales haven't come anywhere near Ozempic's highs, the drug has brought in $3.4 billion in sales for the company last year -- and the addressable market for obesity is much larger than diabetes.

Because, compared to injectables, pills are cheaper to manufacture and generally easier for patients to administer, pharma companies see a weight loss pill as a winning prospect for standing out in an increasingly crowded market.

Novo Nordisk is in a race with several other companies to bring an oral GLP-1 for obesity to market, most notably Eli Lilly whose oral candidate orforglipron has also posted strong data recently. Lilly's CEO told Fortune in January he expects the drug to notch FDA approval in 2026.

Another competitor, Pfizer's danuglipron, had to halt its efforts last month after seeing signs of liver toxicity in late-stage clinical testing, effectively dropping out of the race. Roche and AstraZeneca have candidates as well, but they're both considerably behind Lilly and Novo Nordisk.