FDA approves Eli Lilly’s first-in-class diabetes drug

May 16, 2022

Eli Lilly’s diabetes and weight loss med has been approved by the FDA to improve glycemic control in adults with type 2 diabetes.

The highly anticipated drug, Mounjaro (tirzepatide), is a first-in-class dual-action med that is injected once a week and activates glucose and insulin receptors in the body.  

The approval was granted based on phase 3 trial data showing that patients on the highest dose of Mounjaro lost an average of 12 pounds more than those on Novo Nordisk’s blockbuster Ozempic. The study also compared Mounjaro to other diabetes therapies and was found to be more effective at improving and stabilizing blood sugar levels.

The drug received priority review designation for the current indication, meaning that the agency directed resources to the evaluation of the drug because of the belief that its approval would have a significant impact on the effectiveness of treatment, diagnosis or prevention.

Type 2 diabetes is the most common form of diabetes affecting more than 30 million Americans.

Mounjaro is expected to be available in the U.S. in the coming weeks.