Key Summary
- The pill needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking or using any other oral medication
- In the late-stage study spread over 64 weeks, participants who took the pill daily lost an average of 16.6 percent of their body weight
- Novo is banking on the pill's first-to-market advantage to revitalize sales in the US, where it has lost ground to Lilly
Novo Nordisk's weight-loss pill has been approved by the US Food and Drug Administration, and it will be sold under the brand name Wegovy.
The pill is 25 milligrams of semaglutide, the same active ingredient in injectable Wegovy and Ozempic.
This gives the Danish drugmaker a head start in the race for a potent oral medication for shedding pounds as it looks to regain lost ground from rival Eli Lilly.
Novo already sells an oral semaglutide for type 2 diabetes, Rybelsus.
The approval could help spur a turnaround for Novo after a rocky year of sliding shares, profit warnings and slowing sales of its injectable Wegovy amid intense competition from Lilly and pressure from compounded versions.
A 64-week, late-stage study showed participants who took 25 mg of oral semaglutide once daily lost an average of 16.6 percent of their body weight, compared with 2.7 percent for those on a placebo.
The pill was approved for chronic weight management in adults with obesity and at least one related health condition.
It could help open the door to tens of millions of untapped patients in a global market, forecast to be worth some $150 billion a year by the next decade.
The popularity of Glucagon-like peptide-1 (GLP-1) drugs, which include Novo's semaglutide and Lilly's tirzepatide, used in Mounjaro and Zepbound, has soared in recent years.
The compounds, initially approved for diabetes, can also offer significant weight loss.
First mover advantage
Novo is banking on the pill's first-to-market advantage to revitalise sales in the US, where it has lost ground to Lilly.
Lilly's next-generation weight-loss pill orforglipron could be approved as soon as late March.
David Moore, Novo's executive vice president of US operations, said a daily pill could boost interest and uptake of the drug.
Novo is manufacturing the pill in the United States in North Carolina and has been building up supplies of the pill "for some time" to ensure that it has "ample supply", he said.
The Danish firm had a first-to-market advantage with injectables, but initially struggled to meet explosive demand.
Eventually, Lilly got ahead with its rival Zepbound, which now leads for weekly US prescriptions.
Analysts say a weight-loss pill would address injection hesitancy and expand access.
It could capture around a one-fifth share of the market by 2030, particularly among patients who prefer simpler and less invasive treatment options.
Novo said the 1.5-milligram starting dose of the Wegovy pill will be available in early January.
The pill needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking or using any other oral medication. Lilly's pill does not have those restrictions.
