FDA announces resolution of Wegovy and Ozempic shortage; Hims & Hers shares decline

The long-running U.S. shortage of Novo Nordisk‘s blockbuster weight loss injection Wegovy and diabetes treatment Ozempic is resolved after more than two years, the U.S. Food and Drug Administration said Friday.

The FDA’s decision will threaten the ability of compounding pharmacies to make far cheaper, unbranded versions of the injections over the next few months. Many patients relied on unapproved versions of Wegovy and Ozempic since compounding pharmacies are allowed to make versions of branded medications in short supply.

Novo Nordisk’s stock closed about 5% higher on Friday. Meanwhile, shares of Hims & Hers, a telehealth company offering compounded Wegovy and Ozempic, fell more than 25%.

The active ingredient in both of Novo Nordisk’s injectable drugs, semaglutide, has been in shortage in the U.S. since 2022 after demand skyrocketed. That has forced Novo Nordisk and its rival Eli Lilly to invest heavily to expand their manufacturing footprints for their respective weight loss and diabetes drugs — and it may be paying off.

The FDA determined that Novo Nordisk’s supply and manufacturing capacity for semaglutide injections can now meet the current and projected demand in the U.S. Still, the agency noted that patients and prescribers may still see “intermittent and limited localized supply disruptions” as products move through the supply chain to pharmacies.

“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved,” Dave Moore, Novo Nordisk’s executive vice president of U.S. operations and global business development, said in a statement.

He added that “no one should have to compromise their health due to 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 active ingredient in Eli Lilly’s weight loss injection Zepbound and diabetes counterpart Mounjaro — was over.

The FDA’s decision on Friday could better position Novo Nordisk to compete with Eli Lilly in the booming weight loss drug market, which some analysts say could be worth more than $150 billion annually after 2030.

The agency’s decision, based on a comprehensive analysis, essentially marks the end 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 next 60 to 90 days, depending on the type of facility, the agency said. That transition period will likely give patients time to switch to the branded versions of the medications.

But, in compliance with FDA rules, compounders can still make alternative versions of the drugs if they modify doses, add other ingredients or change the method of giving the treatment to meet a specific patient’s needs.

Some patients rely on compounded versions because they do not have insurance coverage for Novo Nordisk’s drugs and cannot afford their hefty price tags of roughly $1,000 a month. While Ozempic is covered by most health plans, weight loss drugs such as Wegovy are not currently covered by Medicare and other insurance.