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 determination that well being consultants say may open up therapy entry to extra sufferers.
Novo Nordisk mentioned it expects to launch the tablet in early 2026. The Danish drugmaker mentioned beginning in early January, the beginning dose of 1.5 milligrams might be accessible in pharmacies and by way of choose telehealth suppliers with financial savings provides for $149 per 30 days.
That is the identical worth that cash-paying sufferers can entry the beginning dose of the tablet on President Donald Trump’s direct-to-consumer web site, TrumpRx, underneath a deal Novo Nordisk struck along with his administration final month. Trump’s website additionally launches in January.
Novo Nordisk didn’t say how a lot increased doses of the drug would value, however mentioned extra data on protection and financial savings choices for eligible sufferers might be accessible at the moment as effectively.
Shares of Novo Nordisk gained roughly 10% in prolonged buying and selling Monday.
The FDA’s approval additionally clears the tablet to be used to cut back the danger of main cardiovascular occasions, similar to demise, coronary heart assault or stroke, in adults with weight problems and established heart problems, in line with Novo Nordisk. That is in keeping with the approval label of the corporate’s blockbuster weight reduction drug Wegovy, which shares the identical lively ingredient, semaglutide.
“What we have discovered by years of analysis is that having an oral possibility actually form of opens up, prompts and motivates completely 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 may be proper for them.”
“That is what we’re enthusiastic about — to have the ability to give individuals an possibility and ensure we now have entry and ease of entry like we now have been doing with our injections,” he continued.
It is unclear precisely how many individuals are utilizing GLP-1s within the U.S., particularly for weight problems specifically. However round 1 in 8 adults mentioned they had been taking a GLP-1 drug to drop some pounds or deal with one other power situation as of November, in line with a ballot from well being coverage analysis group KFF.
The transfer provides Novo Nordisk a head begin over its chief rival Eli Lilly, which is at the moment the dominant participant out there and is racing to launch its personal weight problems tablet. Drugs are the subsequent battleground for the 2 drugmakers, which established the booming GLP-1 house that some analysts say might be value roughly $100 billion by the 2030s.
Wall Avenue thinks there’s loads of room for tablets out there, with Goldman Sachs analyst saying in August that tablets may seize a 24% share — or round $22 billion — of the 2030 international weight reduction drug market.
In a word Monday, BMO Capital Markets analyst Evan Seigerman mentioned the approval of Novo Nordisk’s tablet provides the corporate a “much-needed win in gentle of current challenges sustaining incretin market share dominance.”
Incretins seek advice from remedies that mimic intestine hormones similar to GLP-1. Eli Lilly earlier this yr gained the bulk share of the market due to its blockbuster weight problems injection Zepbound, which has proven to be more practical than Novo Nordisk’s Wegovy.
“Novo will possible profit from first-mover benefit, capturing sufferers with a choice for comfort and luxury supplied by an oral dosing routine,” Seigerman mentioned. However he additionally famous that the market is “quickly evolving with aggressive property in improvement” and an approval for Eli Lilly’s tablet, orforglipron, “simply across the nook.”
The approval relies on a section three trial that adopted greater than 300 adults with weight problems however not diabetes.
In that examine, 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.
The tablet seems to be barely more practical than an experimental oral drug from Eli Lilly, which remains to be ready for FDA approval.
However not like Novo Nordisk’s tablet, Eli Lilly’s therapy shouldn’t be a peptide treatment. Meaning it’s absorbed extra simply by the physique and doesn’t require dietary restrictions. Individuals who take Novo Nordisk’s tablet have to attend half-hour earlier than consuming or consuming every day.
Moore mentioned the costs of the tablet get prices nearer to what some individuals are paying for unapproved, compounded variations of branded GLP-1s, a few of that are nonetheless being illegally mass-marketed and offered within the U.S.
Sufferers flocked to the cheaper copycats when Ozempic and Wegovy had been briefly provide during the last two years as a result of skyrocketing demand, or in the event that they did not have insurance coverage protection for the pricey remedies. Throughout FDA-declared shortages, pharmacists can legally make compounded variations of brand-name medicines. However the company earlier this yr decided that the scarcity of semaglutide is over, barring the follow in lots of instances.
“It continues to be alarming and disturbing for us,” Moore advised CNBC, referring to illegitimate substances which are imported into the U.S. illegally and utilized by some compounding pharmacies to create copycat variations of branded GLP-1s.
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