- The FDA approved Eli Lilly And Co's (NYSE:LLY) injected drug tirzepatide, which has the brand name Mounjaro (tirzepatide), to help improve blood sugar control in adults with type 2 diabetes.
- The approval covers tirzepatide as an adjunct to diet and exercise.
- As the first and only FDA-approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.
- Mounjaro is designed to activate receptors for hormones involved in blood sugar control. It is administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals.
- Related: Lilly's Tirzepatide Shows Up To 22.5% Weight Loss In New Phase 3 Readout.
- The approval was based on phase 3 SURPASS program results, which included active comparators of injectable semaglutide 1 mg, insulin glargine, and insulin degludec.
- Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5 mg and between 1.7% and 2.4% for both Mounjaro 10 mg and Mounjaro 15 mg.
- While not indicated for weight loss, mean change in body weight was a key secondary endpoint in all SURPASS studies. Participants treated with Mounjaro lost between 12 lb. (5 mg) and 25 lb. (15 mg).
- Price Action: LLY shares are trading 2.93% higher at $299.70 on the last check Monday.
