FDA voices ‘concerns’ with unapproved GLP-1 drugs used for weight loss

The FDA issued a statement in which it states in part: “FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 – glucagon-like peptide-1 receptor agonists – drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.” Novo Nordisk (NVO) markets Ozempic and Wegovy injections and Eli Lilly (LLY) markets its own injectable weight-loss drug as Zepbound. Hims & Hers (HIMS) is a compounder of the weight loss drug whose shares are often volatile around news regarding GLP-1 drugs.