Eli Lilly’s weight-loss drug no longer in shortage, FDA says

Eli Lilly’s (NYSE:LLY) blockbuster GLP-1 medication, tirzepatide, is no longer in shortage in the U.S., the U.S. Food and Drug Administration (FDA) said on Wednesday.

Tirzepatide, currently marketed by Eli Lilly (LLY) as Mounjaro and Zepbound for diabetes and weight loss, respectively, has been in shortage since 2022 due to increased demand.

The drug regulator said it confirmed with Lilly (LLY) that their stated product availability and manufacturing capacity can meet the present and projected national demand.

However, as the products move through the supply chain, patients and prescribers may still see intermittent localized supply disruptions, the agency cautioned.

As the national GLP-1 supply begins to stabilize, the health regulator also clarified its policies for compounders. Compounded drugs are not approved by the FDA and must meet conditions to qualify for exemptions under sections 503A and 503B of the Federal Food, Drug and Cosmetic (FD&C) Act.

“Removal of tirzepatide from FDA shortage list further puts pressure on compounded GLP-1s,” said BMO Capital Markets analyst Evan Seigerman.

Shares of telehealth platform Hims & Hers Health (HIMS), which sells a compounded version of the GLP-1 medication semaglutide, fell over 7% premarket on Thursday. Semaglutide is the active ingredient present in Novo Nordisk’s (NVO) weight loss med Wegovy and diabetes drug Ozempic.

The FDA also clarified that semaglutide injection remains in shortage.