BAGSVÆRD, Denmark: Novo Nordisk scored a key regulatory win on December 22 after U.S. regulators approved its first oral weight-loss treatment, giving the Danish drugmaker a foothold in a fast-growing market increasingly defined by convenience and fierce competition.

The U.S. Food and Drug Administration approved Novo Nordisk's weight-loss pill containing 25 milligrams of semaglutide, the same active ingredient used in its injectable drugs Wegovy and Ozempic. The pill will be sold under the brand name Wegovy. Novo already markets an oral semaglutide, Rybelsus, for type 2 diabetes.

The approval could help revive Novo after a challenging year marked by falling shares, profit warnings, and slowing sales of injectable Wegovy amid intense competition from Eli Lilly and pressure from compounded alternatives. U.S.-listed shares of Novo rose 8 percent in extended trading, while Lilly shares fell one percent.

A 64-week late-stage trial showed patients taking the pill once daily lost an average of 16.6 percent of their body weight, compared with 2.7 percent for those receiving a placebo.

The drug was approved for chronic weight management in adults with obesity or overweight who have at least one related health condition. The broader indication could expand access at a time when insurers, employers, and governments are grappling with rising healthcare costs linked to obesity.

The global obesity-drug market is forecast to reach about US$150 billion annually by the 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 counting on a first-to-market advantage for weight-loss pills in the United States, where it has lost ground to Lilly's injectable Zepbound, which now leads weekly prescriptions. Lilly's next-generation pill, orforglipron, could receive approval as soon as late March.

David Moore, Novo's executive vice president of U.S. operations, said a daily pill could drive greater interest and uptake. Novo is manufacturing the drug in North Carolina and has been building inventory "for some time" to ensure it has "ample supply," he said.

About 40 percent of U.S. adults are obese, government data show, while roughly 12 percent say they currently use GLP-1 drugs, according to a recent poll by KFF.

Novo and analysts say pills could address injection hesitancy and broaden access. Analysts estimate oral drugs could capture around one-fifth of the market by 2030.

"The pills will not displace or replace the injections," said Christopher Chrisman of consultancy BCG. "But pills offer clear advantages to some people. There's travel convenience and no need for a fridge."

Novo said the 1.5-milligram starter dose of the Wegovy pill will be available in early January. Novo and Lilly have agreed to offer starter doses at $149 per month for Medicare and Medicaid beneficiaries and for cash-paying customers through the White House's TrumpRx site. Novo recently cut the cash price of injectable Wegovy to $349 a month from $499, while U.S. list prices typically exceed $1,000.

Novo CEO Mike Doustdar said last month that weight-loss patients behave more like consumers than traditional diabetes patients, underscoring the need for new approaches.

The oral semaglutide must be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or taking other medications — a requirement Lilly's pill does not have.