Nearly two years after reporting successful results from a phase 3 trial of its oral version of injected obesity treatment Wegovy, Novo Nordisk has asked the FDA to approve it.
A company spokesperson confirmed the FDA submission, which was reported Monday by BioPharma Dive. Novo plans to provide more information during its quarterly results presentation May 7, the spokesperson said.
It is unusual for a company to not voluntarily announce an FDA new drug submission. It also is rare that a submission comes two years after the presentation of successful results of a pivotal trial.
In May 2023, when Novo reported that patients on the highest dose (50 mg) of oral semaglutide lost 15% of their weight after 64 weeks, the company said it planned to apply for approval by the end of that year.
On Tuesday, a company spokesperson said that Novo was "awaiting the results from the entire OASIS program to include a full package for submission."
For the last few years, Novo has been focused on trying to meet the skyrocketing demand for Wegovy and diabetes drug Ozempic. With the company struggling to increase its production of the glucagon-like peptide-1 (GLP-1) treatments, finding additional capacity to manufacture oral semaglutide—provided it won approval—was a secondary priority for the company.
Additionally, over the last few years, Novo has poured more resources into the development of another obesity treatment—dual-action CagriSema—which it once touted as having the potential to trigger 25% weight loss.
But the shine has come off that treatment as it produced a disappointing 16% weight reduction in a second phase 3 trial, the results of which were reported last month. Since then, Novo’s share price has fallen 36%.
Strong trial results for orforglipron—a GLP-1 pill from market rival Eli Lilly—have also contributed to the declining share price for Novo.
Before the release of Novo's CagriSema study results, many assumed the candidate had the potential to become the preferred option in the oral weight loss treatment market. Now, it appears Lilly and Novo will initially compete with their respective GLP-1 pills, with Novo hoping for a first-to-the-market edge with its submission.
Novo already sells Rybelsus, an oral semaglutide treatment for diabetes patients, which comes in doses of 7 mg and 14 mg. The company reported sales of 23.3 billion Danish kroner ($3.4 billion) for Rybelsus last year, which were up 26% year over year. Three weeks ago, Novo submitted Rybelsus for a label expansion to help heart disease patients reduce their risk of cardiovascular events.