The Food and Drug Administration (FDA) has granted Fast Track designation to Lilly’s tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities.

Tirzepatide is a once-weekly, duel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist that integrates the actions of both incretins into a single molecule.

The designation was based on positive data from the phase 3 SURMOUNT-1 trial (ClinicalTrials.gov Identifier: NCT04184622), which evaluated the efficacy and safety of tirzepatide as an adjunct to a reduced-calorie diet and increased physical activity in 2539 adults without type 2 diabetes who have obesity, or are overweight with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. Treatment with tirzepatide was associated with significant weight loss in this trial; the most common adverse events reported were gastrointestinal-related.

The Company is also investigating tirzepatide in overweight and obese individuals with type 2 diabetes in the phase 3 SURMOUNT-2 trial (ClinicalTrials.gov Identifier: NCT04657003). Results from this study are expected at the end of April 2023.

“We are pleased with the FDA’s decision to grant Fast Track designation for tirzepatide, and we look forward to completing our rolling submission next year,” said Mike Mason, president, Lilly Diabetes. 

Tirzepatide is currently approved under the brand name Mounjaro® as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on data from the SURPASS clinical program, which included 5 clinical trials that assessed Mounjaro as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Significant weight reductions were observed in tirzepatide-treated patients across these studies.

Reference

Lilly receives US FDA Fast Track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. News release. October 6, 2022. https://www.prnewswire.com/news-releases/lilly-receives-us-fda-fast-track-designation-for-tirzepatide-for-the-treatment-of-adults-with-obesity-or-overweight-with-weight-related-comorbidities-301642476.html