Novo Nordisk files for FDA approval of first oral GLP-1 weight loss pill​

DENMARK – Novo Nordisk has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for a 25 mg oral version of its GLP-1 receptor agonist, semaglutide, intended for the treatment of overweight and obesity.

This submission marks a significant milestone as it represents the first potential approval of a GLP-1 receptor agonist in pill form specifically for weight loss. ​

The company confirmed that the application was filed earlier this year, aligning with statements made by CEO Lars Fruergaard Jørgensen in February.

Further details regarding the submission, including the FDA’s decision timeline, are expected to be disclosed during Novo Nordisk’s upcoming quarterly results presentation on May 7. ​

This development positions Novo Nordisk ahead of its competitor, Eli Lilly, which has announced plans to seek FDA approval for its own oral GLP-1 drug, orforglipron, for weight management by the end of this year.

While pivotal data for orforglipron in obesity have yet to be announced, early Phase III results in adults with type 2 diabetes have shown promising weight loss outcomes. ​

In its own late-stage program, Novo Nordisk’s oral semaglutide at a 50 mg dose led to a 15.1% reduction in body weight in adults with obesity or overweight after 68 weeks, compared to a 2.4% reduction with placebo, as observed in the OASIS 1 study.

More recently, the OASIS 4 trial demonstrated that a 25 mg dose resulted in a 13.6% weight loss after 64 weeks, versus 2.2% for placebo.

Novo Nordisk already markets Rybelsus, an oral semaglutide treatment for type 2 diabetes, available in 7 mg and 14 mg doses.

The company reported sales of 23.3 billion Danish kroner (US$ 3.4 billion) for Rybelsus last year, reflecting a 26% year-over-year increase.

Recently, Novo submitted Rybelsus for a label expansion to include cardiovascular risk reduction in heart disease patients.

The introduction of an oral GLP-1 therapy for weight loss could significantly impact the obesity treatment landscape, offering a more convenient alternative to injectable options like Wegovy.