Eli Lilly gets USFDA Fast Track designation for Tirzepatide to treat adults with obesity

Based on discussions with the USFDA, 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," the company stated.

"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."