Tirzepatide Fast Track Designation by FDA

The U.S. Food and Drug Administration (FDA) has Fast Tracked tirzepatide for the treatment of weight-related comorbidities, patients with obesity, or overweight.

Tirzepatide is a once-weekly subcutaneous injection engineered from the native GIP sequence, with agonist activity at both the GIP and GLP-1 receptors. It is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist that integrates the actions of both incretins into a single molecule.

Fast Track Status and Clinical Trials

The fast track status was granted on the basis of positive data from the phase 3 SURMOUNT-1 trial (ClinicalTrials.gov Identifier: NCT04184622) in which the efficacy and safety of tirzepatide was evaluated as an adjunctive measure 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 one of the following comorbidities:

• Hypertension
• Dyslipidemia
• Obstructive sleep apnea
• Cardiovascular disease

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.

Statements from Lilly

"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."

References

1. Jastreboff, A., Arrone, J., Ahmad, N. et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med 2022; 387:205-216 DOI: 10.1056/NEJMoa2206038
2. le Roux, C. Zhang, S., Aronne, L. et. al. Tirzepatide for the Treatment of Obesity: Rationale and Design of the SURMOUNT Clinical Development Program 2022 Obesity doi: 10.1002/oby.23612