Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy.
Hollie Adams | Reuters
The long-running U.S. shortage of Novo Nordisk‘s blockbuster weight reduction injection Wegovy and diabetes treatment Ozempic is resolved after greater than two years, the U.S. Food and Drug Administration said Friday.Â
The FDA’s decision will threaten the flexibility of compounding pharmacies to make far cheaper, unbranded versions of the injections over the subsequent few months. Many patients relied on unapproved versions of Wegovy and Ozempic since compounding pharmacies are allowed to make versions of branded medications in brief supply.Â
Novo Nordisk’s stock closed about 5% higher on Friday. Meanwhile, shares of Hims & Hers, a telehealth company offering compounded Wegovy and Ozempic, fell greater than 25%.
The energetic ingredient in each of Novo Nordisk’s injectable drugs, semaglutide, has been in shortage within the U.S. since 2022 after demand skyrocketed. That has forced Novo Nordisk and its rival Eli Lilly to take a position heavily to expand their manufacturing footprints for his or her respective weight reduction and diabetes drugs — and it might be paying off.Â
The FDA determined that Novo Nordisk’s supply and manufacturing capability for semaglutide injections can now meet the present and projected demand within the U.S. Still, the agency noted that patients and prescribers should see “intermittent and limited localized supply disruptions” as products move through the provision chain to pharmacies.Â
“We’re pleased the FDA has declared that provide of the one real, FDA-approved semaglutide medicines is resolved,” Dave Moore, Novo Nordisk’s executive vp of U.S. operations and global business development, said in an announcement.
He added that “nobody should should compromise their health on account of misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients.”
The FDA’s announcement comes just months after the agency declared the shortage of tirzepatide — the energetic ingredient in Eli Lilly’s weight reduction injection Zepbound and diabetes counterpart Mounjaro — was over.Â
The FDA’s decision on Friday could higher position 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 annually after 2030.Â
Threat to compounded medications
The agency’s decision, based on a comprehensive evaluation, essentially marks the tip of a period where compounding pharmacies could make, distribute or dispense unapproved versions of semaglutide without facing repercussions for violations related to the treatment’s shortage status.
Compounding pharmacies must stop making compounded versions of semaglutide in the subsequent 60 to 90 days, depending on the style of facility, the agency said. That transition period will likely give patients time to modify to the branded versions of the medications.Â
But, in compliance with FDA rules, compounders can still make alternative versions of the drugs in the event that they modify doses, add other ingredients or change the strategy of giving the treatment to fulfill a selected patient’s needs.Â
Some patients depend on compounded versions because they wouldn’t have insurance coverage for Novo Nordisk’s drugs and can’t afford their hefty price tags of roughly $1,000 a month. While Ozempic is roofed by most health plans, weight reduction drugs akin to Wegovy are usually not currently covered by Medicare and other insurance.
