Eli Lilly Gets Fast Track Status for Tirzepatide in Obese and Overweight Adults
Eli Lilly has received FDA’s Fast Track designation for tirzepatide for treatment of adults with obesity or who are overweight with weight-related comorbidities.
Tirzepatide is a once-weekly glucose-dependent insulinotropic polypeptide receptor and GLP-1 glucagon-like peptide-1 receptor agonist. The drug activates the two receptors, which decreases blood glucose levels.
The company plans to begin a rolling submission to the FDA of a New Drug Application (NDA) sometime this year supported by two phase 3 clinical trials.
The drug is FDA-approved as Mounjaro as an adjunct treatment, along with diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. Mounjaro was approved for this indication in May.