Novo Nordisk Gets US Approval For Wegovy Obesity Pill
The approval was based on the results of the Oasis 4 trial, which found people taking a 25 milligram pill once daily lost about 16.6% of their body weight.
Novo Nordisk A/S won approval to sell a pill version of its blockbuster obesity shot Wegovy in the US, a crucial step in its effort to defend its market share from rival Eli Lilly & Co.
Novo will start selling the pill, the first of the blockbuster GLP-1 class, in the US in early January, the company said in a statement Monday. It is approved to help people lose weight or maintain previous weight loss over the long term.
The approval was based on the results of the Oasis 4 trial, which found people taking a 25 milligram pill once daily lost about 16.6% of their body weight. The company said it filed for approval in Europe and other parts of the world in the second half of 2025.
The pill is crucial for Novo’s strategy to take on Lilly, which has said its own oral obesity drug could be approved by March. That would give Novo a head start of just a few months.
Novo’s American depositary receipts rose more than 8% in after-hours trading. They have slumped 44% this year on investors’ concerns about its position in the market.
The company plans to sell the 1.5 milligram dose of the pill to cash-pay patients at a starting price of $149 a month. Details about the cost for higher doses and the price for those using insurance will be disclosed closer to the time of launch, the company said in an email, noting the insurance-covered price could be as low as $25 per month across all doses.
“The Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey,” Novo Chief Executive Officer Mike Doustdar said in the statement. “No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US.”
Novo has been struggling to compete recently in the obesity market it did so much to create. Its flagship drug Wegovy has lost ground to Lilly’s Zepbound, as a head-to-head trial showed Zepbound could help people lose more weight. Novo’s next-generation shot CagriSema also failed to deliver as much weight loss as the company had promised in studies.
The Danish drugmaker is relying on the new pill to fuel growth, and has said it will sell the drug via telehealth platforms as well as more traditional channels.
