The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's oral obesity treatment orforglipron, setting the stage for intensified competition in the GLP-1 class obesity drug market. The expansion from an injection-dominated market to pills is raising the prospect of a significant shift in the competitive landscape.
The FDA approved Lilly's GLP-1 weight-loss pill orforglipron, Reuters reported Monday. The product will be sold under the brand name Foundayo and is scheduled for launch on April 6.
Foundayo is a once-daily oral GLP-1 treatment that demonstrated approximately 12% to 15% weight loss in clinical trials. Notably, it can be taken regardless of food intake, offering greater convenience compared to existing oral GLP-1 drugs that require fasting before administration.
"It will be a suitable treatment not only for weight loss but also for patients aiming to maintain their weight," Eli Lilly CEO David Ricks said, adding that the company has filed for approval in more than 40 countries.
The approval puts Lilly in direct competition with Novo Nordisk in the GLP-1 market. Novo Nordisk has already secured a dominant position with its injectable obesity treatment Wegovy and diabetes drug Ozempic, and moved ahead in the oral market by launching a pill earlier this year. However, Lilly's product is seen as having a competitive edge in dosing convenience.
Injections currently dominate the GLP-1 market, but oral treatments are expected to play a key role in attracting new patients. Industry analysts project oral obesity drugs will account for approximately 20% of the total market by 2030.
The price has been set at $149 per month for self-pay patients at the lowest dose. Reported side effects include gastrointestinal symptoms such as nausea and vomiting, and the label carries a warning about thyroid tumor risk.
The approval came through the U.S. government's expedited approval program, which accelerates reviews for drugs of significant public health importance. Lilly reportedly received the designation through an agreement with the government that included conditions such as drug price reductions.