The oral version of Wegovy is proving to have similar efficacy, safety, and tolerability when compared to its injectable version.
Clinical trial data suggest that Novo Nordisk's oral Wegovy is ahead of the pack, and it could receive FDA approval this year.
Novo Nordisk (NYSE: NVO) shares surged by 12.7% in the week to Friday morning as investors received positive news on an orally administered weight loss drug pivotal to the company's future.
With Novo Nordisk's Wegovy (semaglutide) seen as losing market share in the subcutaneous (injectable) weight loss drug market to Eli Lilly's Zepbound, the race is on to commercialize an orally administered drug, not least because an oral version will have significant convenience advantages over an injectable one.
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That said, there are challenges involved in producing an orally administered weight loss drug, including the usual issues of demonstrating efficacy, as well as safety and tolerability. The good news is that Novo Nordisk's orally administered Wegovy (semaglutide) appears to be ahead of the field of GLP-1 drugs.
For example, Viking Therapeutics' promising VK2735 recently reported disappointing safety and tolerability data in a phase 2 trial in oral form. Meanwhile, Novo Nordisk's oral Wegovy appears to have an edge in efficacy, safety, tolerability over Eli Lilly's orforglipron in clinical trials for weight loss. However, Eli Lilly recently released results from a study claiming superiority in efficacy over oral Wegovy in diabetes -- for reference, the study wasn't powered to compare safety and tolerability.
Image source: Getty Images.
Turning back to the updated news, the results of Novo Nordisk's Oasis 4 phase 3 trial demonstrated an average weight loss of 16.6% on a 25mg dosage after 64 weeks, which is "comparable with previous trial results of injectable Wegovy," and "a safety and tolerability profile consistent with injectable Wegovy," according to the press release.
Management continues to expect the completion of a U.S. Food and Drug Administration (FDA) review of the drug by year-end, which could lead to its approval as the first orally administered weight loss drug in its class for the market. That's why investors are excited this week.
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Lee Samaha has no position in any of the stocks mentioned. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy.