Weight loss drug Zepbound is no longer in short supply, FDA says

Missing Eli Lilly (LLY) blockbuster drugs for diabetes and weight loss are officially over, according to the US Food and Drug Administration (FDA).

The FDA updated its drug shortage database on Wednesday, marking the shortage of popular drugs as resolved. The news could put pressure on companies that have been able to sell off-brand versions of GLP-1 weight loss drugs because of widespread shortages.

GLP-1 drugs, which mimic blood sugar-regulating and appetite-suppressing hormones, have become highly sought after for their weight-loss effects. Growing demand for these treatments turned Eli Lilly and its rival Novo Nordisk (NGOs), producer Ozempic and Wegovy, in the most valuable pharmaceutical companies in the world. The skyrocketing demand has made it difficult for some patients to fill their prescriptions.

Eli Lilly’s Mounjaro has been added to the FDA’s drug shortage database in 2022, while Zepbound was added in April.

Eli Lilly did not immediately respond to a request for comment from Quartz.

Low-cost competitors are not thrilled

The millennial-focused telehealth platform Hims & Hers (HE), which recently began offering a combination version of semaglutide — the active ingredient in Wegovy — saw its stock drop more than 11 percent during Wednesday’s trading session.

composing refers to the customization of an approved drug by a pharmacy or physician to meet the specific needs of an individual patient.

Usually, the Food, Drug and Cosmetic Act prohibits compounding of drugs that are merely copies of commercially available drugs. But drugs that are in short supply are not considered by the FDA to be commercially available. The limited supply of highly coveted and expensive brand-name weight loss drugs has led several digital healthcare companies to take advantage of this provision.

Hims & Hers did not immediately respond to a request for comment.

In July, the company added Kåre Schultz, a longtime Novo Nordisk executive, to its board. At the time, Schultz Bloomberg said that the company has a “long future” in selling the compound semaglutide.

When asked if pharmacies would still be able to make compounded semaglutide after the shortage ends, Schulz said he wasn’t worried because there would still be cases where patients needed individualized prescriptions.

Geoff Cook, CEO of recently launched weight loss app Noom providing compound semaglutide to its members, urged regulators in September to proceed with caution when considering lifting the deficit declaration for brand-name weight loss drugs. He warned that ending the declaration too soon could restrict consumers’ access to more affordable alternatives.

“We hope that regulators and policymakers are cautious when they realize that ending this shortage may result in millions of people being unable to access obesity medications,” Cook said.