FDA approves first GLP-1 tablet for weight problems from Wegovy maker Novo Nordisk

The U.S. Meals and Drug Administration on Monday authorized the first-ever GLP-1 tablet for weight problems from Wegovy maker Novo Nordisk, a landmark resolution that well being consultants say may probably open up therapy entry to extra sufferers.

Novo Nordisk mentioned it expects to launch the tablet in early 2026. The Danish drugmaker mentioned the beginning dose of 1.5 milligrams might be out there beginning in early January in pharmacies and by way of choose telehealth suppliers for $149 per 30 days.

Novo Nordisk didn’t say how a lot increased doses of the drug would value, however mentioned extra info on protection and financial savings choices for eligible sufferers might be out there at the moment as nicely.

Shares of Novo Nordisk gained roughly 10% in prolonged buying and selling.

The approval provides Novo Nordisk a head begin over chief rival Eli Lilly, which is at present the dominant participant available in the market and is racing to launch its personal weight problems tablet. Drugs are the following battleground for the 2 drugmakers, which established the booming GLP-1 area that some analysts say could possibly be value roughly $100 billion by the 2030s.

Wall Avenue thinks there’s loads of room for tablets available in the market, with Goldman Sachs analyst saying in August that tablets may seize a 24% share — or round $22 billion — of the 2030 world weight reduction drug market.

“What we have realized by way of years of analysis is that having an oral choice actually form of opens up, prompts and motivates totally different segments to hunt therapy,” Dave Moore, Novo Nordisk’s government vp of U.S. operations, advised CNBC forward of the approval. “To have that dialog with their physician to see if that is one thing that is likely to be proper for them.”

“That is what we’re enthusiastic about — to have the ability to give individuals an choice and ensure we’ve entry and ease of entry like we’ve been doing with our injections,” he continued.

The FDA’s approval additionally clears the tablet to be used to cut back the chance of main cardiovascular occasions, resembling dying, coronary heart assault or stroke, in adults with weight problems and established heart problems, in line with Novo Nordisk. That is according to the approval label of the corporate’s blockbuster weight reduction drug Wegovy, which shares the identical lively ingredient, semaglutide.

The approval is predicated on a part three trial that adopted greater than 300 adults with weight problems however not diabetes.

In that research, a 25-milligram dose of Novo Nordisk’s oral semaglutide helped sufferers lose as much as 16.6% of their weight on common after 64 weeks, in line with outcomes from the trial introduced at a medical convention in 2024. That weight reduction was 13.6% when the corporate analyzed all sufferers no matter whether or not they stopped the drug.

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