Lilly receives FDA Fast Track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.

Based on discussions with the FDA, Lilly plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be based primarily on results from two Phase 3 clinical trials: SURMOUNT-1, which is complete, and SURMOUNT-2, which is expected to complete by the end of April 2023. The rolling submission allows Lilly to submit completed sections of an application for review by FDA, rather than wait until all sections are completed.

Assuming positive SURMOUNT-2 results, Lilly aims to complete the submission shortly after SURMOUNT-2 data is available. The Fast Track designation, along with a rolling submission, accelerates tirzepatide’s path to FDA submission.

“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. “Obesity is a chronic disease that impacts the health of nearly 100 million Americans and is a significant driver of healthcare costs. While diet and exercise are important steps, most patients don’t achieve their desired treatment goals with only diet and exercise. We are dedicated to helping people living with obesity through our research and development of innovative treatments like tirzepatide, which produced significant weight reductions in patients taking tirzepatide for type 2 diabetes in SURPASS. Tirzepatide also helped nearly two-thirds of participants on the highest dose reduce their body weight by at least 20 percent in SURMOUNT-1.”