The U.S. Meals and Drug Administration on Monday authorized 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 therapy 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 might be obtainable in pharmacies and through choose telehealth suppliers with financial savings presents for $149 per 30 days.
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, underneath a deal Novo Nordisk struck together with his administration final month. Trump’s website additionally launches in January.
Novo Nordisk didn’t say how a lot larger doses of the drug would price, however mentioned further data on protection and financial savings choices for eligible sufferers might be obtainable 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, akin to dying, coronary heart assault or stroke, in adults with weight problems and established heart problems, in keeping with Novo Nordisk. That is per the approval label of the corporate’s blockbuster weight reduction drug Wegovy, which shares the identical energetic ingredient, semaglutide.
“What we have realized by years of analysis is that having an oral possibility actually sort 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 could be proper for them.”
“That is what we’re enthusiastic about — to have the ability to give folks an possibility and ensure we’ve got entry and ease of entry like we’ve got 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 have been taking a GLP-1 drug to reduce weight or deal with one other continual situation as of November, in keeping 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 present the dominant participant out there and is racing to launch its personal weight problems capsule. Tablets are the subsequent battleground for the 2 drugmakers, which established the booming GLP-1 area that some analysts say may very well be price 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 world weight reduction drug market.
In a notice 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 consult with therapies that mimic intestine hormones akin 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 desire for comfort and luxury supplied by an oral dosing routine,” Seigerman mentioned. However he additionally famous that the market is “quickly evolving with aggressive belongings in improvement” and an approval for Eli Lilly’s capsule, orforglipron, “simply across the nook.”
The approval relies 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, in keeping with outcomes from the trial offered 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 more practical than an experimental oral drug from Eli Lilly, which continues to be ready for FDA approval.
However in contrast to Novo Nordisk’s capsule, Eli Lilly’s therapy just isn’t a peptide remedy. 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 consuming every day.
Moore mentioned the costs of the capsule 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 bought within the U.S.
Sufferers flocked to the cheaper copycats when Ozempic and Wegovy have been briefly provide during the last two years on account of skyrocketing demand, or in the event that they did not have insurance coverage protection for the expensive therapies. 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 apply in lots of instances.
“It continues to be alarming and disturbing for us,” Moore advised CNBC, referring to illegitimate components which can be imported into the U.S. illegally and utilized by some compounding pharmacies to create copycat variations of branded GLP-1s.
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