FDA has approved Mounjaro (tirzepatide), the first glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) for treating adults with type 2 diabetes.
Developed by Eli and Co., tirzepatide could quickly become a mega-blockbuster. According to Mizuho Securities, annual sales of the drug could approach $14 billion by 2030.
To win approval, Lilly provided data from the Phase 3 SURPASS clinical studies showing that it supported superior A1C reductions than all comparators, including insulin glargine and insulin degludec. The SURPASS trials also pitted tirzepatide against metformin, SGLT2 inhibitors and sulfonylureas.
The drug also has the side benefit of supporting weight loss, although it is not indicated for obesity. Volunteers in the SURPASS trials lost an average of 12 and 25 lb., depending on dose level.
In the SURMOUNT-1 study, the drug yielded up to 22.5% in adults with obesity or overweight.
Lilly will market the drug in an auto-injector pin with a hidden needle. It will be available in six doses ranging from 2.5 to 15 mg.
LLY shares were mostly flat, holding steady at $291.63.
Lilly is also pursuing commercialization of tirzepatide in Europe, Japan and other regions.
The company is also investigating tirzepatide for potential indications including heart failure, obesity and non-alcoholic steatohepatitis.