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 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 III 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.
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