Eli Lilly Gets FDA Fast-Track Designation for Tirzepatide in Obesity

By Colin Kellaher

Eli Lilly & Co. on Thursday said the U.S. Food and Drug Administration granted fast-track designation to its diabetes drug tirzepatide for the treatment of adults with obesity or who are overweight with weight-related comorbidities.

The Indianapolis drugmaker said it plans to initiate a rolling submission of a new-drug application for the indication this year.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

The FDA in May approved tirzepatide as Mounjaro to improve blood-sugar control in adults with type 2 diabetes, as an addition to diet and exercise.

Eli Lilly in April said a Phase 3 study of tirzepatide met its key endpoints in obese or overweight adults who don't have diabetes.

The company said its rolling submission, which lets it file completed sections of the application for review by FDA rather than wait until all sections are complete, will be based mainly on that study and a second Phase 3 trial slated to wrap up by the end of April 2023.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

October 06, 2022 07:22 ET (11:22 GMT)

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