The U.S. Meals and Drug Administration on Monday accepted the first-ever GLP-1 capsule for weight problems from Wegovy maker Novo Nordisk, a landmark choice that well being specialists say may open up remedy entry to extra sufferers.
Novo Nordisk mentioned it expects to launch the capsule in early 2026. The Danish drugmaker mentioned beginning in early January, the beginning dose of 1.5 milligrams will likely be accessible in pharmacies and through choose telehealth suppliers with financial savings presents for $149 monthly.
That is the identical worth that cash-paying sufferers can entry the beginning dose of the capsule on President Donald Trump’s direct-to-consumer web site, TrumpRx, beneath 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 info on protection and financial savings choices for eligible sufferers will likely be accessible at the moment as properly.
Shares of Novo Nordisk gained roughly 10% in prolonged buying and selling Monday.
The FDA’s approval additionally clears the capsule to be used to scale back the danger of main cardiovascular occasions, reminiscent of dying, coronary heart assault or stroke, in adults with weight problems and established heart problems, based on 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.
“What we have discovered by means of years of analysis is that having an oral choice actually form of opens up, prompts and motivates totally different segments to hunt remedy,” 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 now we have entry and ease of entry like now we have been doing with our injections,” he continued. He added that sufferers could have the “consolation and familiarity” on the security and efficacy facet because the capsule comprises the identical lively ingredient as Wegovy.
It is unclear precisely how many individuals are utilizing GLP-1s within the U.S., particularly for weight problems particularly. However round 1 in 8 adults mentioned they have been taking a GLP-1 drug to drop pounds or deal with one other continual situation as of November, based on 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 available in the market and is racing to launch its personal weight problems capsule. Tablets are the following battleground for the 2 drugmakers, which established the booming GLP-1 house that some analysts say may very well be value roughly $100 billion by the 2030s.
Wall Road thinks there’s loads of room for capsules available in the market, with Goldman Sachs analyst saying in August that capsules may seize a 24% share — or round $22 billion — of the 2030 world weight reduction drug market.
In a observe Monday, BMO Capital Markets analyst Evan Seigerman mentioned the approval of Novo Nordisk’s capsule provides the corporate a “much-needed win in mild of latest challenges sustaining incretin market share dominance.”
Incretins confer with remedies that mimic intestine hormones reminiscent of 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 simpler than Novo Nordisk’s Wegovy.
“Novo will seemingly profit from first-mover benefit, capturing sufferers with a choice for comfort and luxury offered by an oral dosing routine,” Seigerman mentioned. However he additionally famous that the market is “quickly evolving with aggressive belongings in growth” and an approval for Eli Lilly’s capsule, orforglipron, “simply across the nook.”
The approval is predicated on a part 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, based on 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 capsule seems to be barely simpler than an experimental oral drug from Eli Lilly, which continues to be ready for FDA approval.
However not like Novo Nordisk’s capsule, Eli Lilly’s remedy shouldn’t be a peptide medicine. Meaning it’s absorbed extra simply by the physique and doesn’t require dietary restrictions. Individuals who take Novo Nordisk’s capsule have to attend half-hour earlier than consuming or ingesting every day.
However Moore mentioned a number of present medicines have the identical dietary necessities, so “we do not see it as one thing that impacts adherence to remedy.” He famous that Novo Nordisk’s analysis has discovered that it helps sufferers to recollect to take their drugs within the morning with a couple of sips of water.
“It is really a reinforcement issue for sufferers,” Moore mentioned.
He added that the costs of the capsule get prices nearer to what some persons are paying for unapproved, compounded variations of branded GLP-1s, a few of that are nonetheless being illegally mass-marketed and bought within the U.S.
Sufferers flocked to the cheaper copycats when Ozempic and Wegovy have been briefly provide during the last two years attributable to 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 drugs. However the company earlier this yr decided that the scarcity of semaglutide is over, barring the apply in lots of instances.
“It continues to be alarming and disturbing for us,” Moore advised CNBC, referring to illegitimate components which might be imported into the U.S. illegally and utilized by some compounding pharmacies to create copycat variations of branded GLP-1s.
By way of manufacturing, Moore mentioned the corporate is “ready to have the ability to fulfill a giant demand right here within the U.S., and we’re fairly enthusiastic about it.”
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