Containers of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy.
Hollie Adams | Reuters
The long-running U.S. scarcity of Novo Nordisk‘s blockbuster weight reduction injection Wegovy and diabetes therapy Ozempic is resolved after greater than two years, the U.S. Meals and Drug Administration stated Friday.
The FDA’s determination will threaten the flexibility of compounding pharmacies to make far cheaper, unbranded variations of the injections over the subsequent few months. Many sufferers relied on unapproved variations of Wegovy and Ozempic since compounding pharmacies are allowed to make variations of branded drugs in brief provide.
Novo Nordisk’s inventory closed about 5% larger on Friday. In the meantime, shares of Hims & Hers, a telehealth firm providing compounded Wegovy and Ozempic, fell greater than 25%.
The lively ingredient in each of Novo Nordisk’s injectable medication, semaglutide, has been in scarcity within the U.S. since 2022 after demand skyrocketed. That has pressured Novo Nordisk and its rival Eli Lilly to take a position closely to develop their manufacturing footprints for his or her respective weight reduction and diabetes medication — and it could be paying off.
The FDA decided that Novo Nordisk’s provide and manufacturing capability for semaglutide injections can now meet the present and projected demand within the U.S. Nonetheless, the company famous that sufferers and prescribers should see “intermittent and restricted localized provide disruptions” as merchandise transfer via the provision chain to pharmacies.
“We’re happy the FDA has declared that provide of the one actual, FDA-approved semaglutide medicines is resolved,” Dave Moore, Novo Nordisk’s government vice chairman of U.S. operations and international enterprise growth, stated in a press release.
He added that “nobody ought to need to compromise their well being resulting from misinformation and attain for pretend or illegitimate knockoff medication that pose important security dangers to sufferers.”
The FDA’s announcement comes simply months after the company declared the scarcity of tirzepatide — the lively ingredient in Eli Lilly’s weight reduction injection Zepbound and diabetes counterpart Mounjaro — was over.
The FDA’s determination on Friday may higher place Novo Nordisk to compete with Eli Lilly within the booming weight reduction drug market, which some analysts say may very well be price greater than $150 billion yearly after 2030.
Risk to compounded drugs
The company’s determination, based mostly on a complete evaluation, basically marks the tip of a interval the place compounding pharmacies may make, distribute or dispense unapproved variations of semaglutide with out going through repercussions for violations associated to the therapy’s scarcity standing.
Compounding pharmacies should cease making compounded variations of semaglutide within the subsequent 60 to 90 days, relying on the kind of facility, the company stated. That transition interval will probably give sufferers time to change to the branded variations of the drugs.
However, in compliance with FDA guidelines, compounders can nonetheless make different variations of the medication in the event that they modify doses, add different components or change the strategy of giving the therapy to fulfill a selected affected person’s wants.
Some sufferers depend on compounded variations as a result of they don’t have insurance coverage protection for Novo Nordisk’s medication and can’t afford their hefty value tags of roughly $1,000 a month. Whereas Ozempic is roofed by most well being plans, weight reduction medication equivalent to Wegovy should not at the moment coated by Medicare and different insurance coverage.
