The U.S. Food and Drug Administration approved Novo Nordisk’s weight-loss pill on Monday, giving the Danish drugmaker a leg up in the race to market a potent oral medication for shedding pounds as it looks to regain lost ground from rival Eli Lilly.
The pill is 25 milligrams of semaglutide, the same active ingredient in injectable Wegovy and Ozempic, and will be sold under the brand name Wegovy. 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.
U.S.-listed shares of Novo jumped 8% and Lilly fell 1% in extended trading after the approval announcement.
A 64-week, late-stage study showed participants who took 25 mg of oral semaglutide once daily lost an average of 16.6% of their body weight, compared with 2.7% for those on a placebo.
The pill was approved for chronic weight management in adults with obesity or overweight and at least one related health condition, broadening the potential patient pool at a time when insurers, employers and governments are wrestling with spiraling healthcare costs related to obesity.
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 next decade.
“You’re going to see a huge uptake in the patient base as new indications open up and as oral versions hit the market,” said Anand Iyer, chief AI officer at telehealth firm Welldoc.
Novo is banking on the pill’s first-to-market advantage to revitalize sales in the U.S., 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 U.S. 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.
Some 40% of American adults are obese, U.S. government data shows, and around 12% say they currently take GLP-1 drugs, according to a poll published last month by health policy research organization KFF.
Novo 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 U.S. prescriptions.
Novo and analysts say a weight-loss pill would address injection hesitancy and expand access.
Analysts say pills could capture around a one-fifth share of the market by 2030, particularly among patients who prefer simpler and less invasive treatment options.
“The pills will not displace or replace the injections,” said Christopher Chrisman, a managing director and partner at consultancy BCG, adding some patients may prefer to continue with weekly injections.
“But pills offer clear advantages to some people. There’s travel convenience and no need for a fridge,” he added.
PRICING AGREEMENTS
Novo said the 1.5-milligram starting dose of the Wegovy pill will be available in early January.
Novo and Lilly had agreed to offer starter doses of their weight‑loss pills at $149 per month for the U.S. government Medicare and Medicaid health insurance programs and to cash-paying customers via the White House’s direct-to-consumer TrumpRx site.
Novo recently cut the cash price for Wegovy to $349 a month, from $499. U.S. list prices are about $1,000 per month or more.
Novo CEO Mike Doustdar said in November that people using weight-loss drugs show more “consumer-like” behavior than its traditional diabetes patients, acknowledging that the company needs to adapt to this and bring in new expertise.
Whether another semaglutide product can solve Novo’s current ills remains to be seen.
Novo’s oral semaglutide 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.
(Reporting by Maggie Fick, Patrick Wingrove, Mariam Sunny, Christy Santhosh and Mrinalika Roy; Editing by Adam Jourdan, Bill Berkrot, Rosalba O’Brien and Jamie Freed)
—Maggie Fick and Mariam Sunny, Reuters