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Eli Lilly's Obesity Drug, Tirzepatide, Fast Tracked In US; Rolling Submission To Start This Year

  • The FDA has granted Fast Track designation for Eli Lilly And Co's (NYSE: LLY) tirzepatide for adults with obesity or overweight with weight-related comorbidities.

  • Based on discussions with the FDA, Lilly plans to initiate a rolling submission of a marketing application for tirzepatide 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.

  • Assuming positive SURMOUNT-2 results, Lilly aims to complete the submission shortly after SURMOUNT-2 data is available. The Fast Track designation and a rolling submission accelerate tirzepatide's path to FDA submission.

  • Related: Eli Lilly Presents New Analyses On Tirzepatide Injection For Type 2 Diabetes.

  • The SURMOUNT Phase 3 global clinical development program for tirzepatide began in late 2019 and has enrolled more than 5,000 people across six clinical trials, four of which are global studies. Results from SURMOUNT-2, -3, and -4 are anticipated in 2023.

  • Price Action: LLY shares are up 0.82% at $334.50 on the last check Thursday.

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