FDA Grants Fast Track Designation to Tirzepatide for Treatment of Obesity, Overweight in Adults

The US Food and Drug Administration (FDA) today granted fast track designation for the investigation of tirzepatide (Mounjaro®) for the treatment of adults with obesity or overweight with weight-related comorbidities, announced the manufacturer, Eli Lilly and Company.

Tirzepatide, a first-in-class dual incretin receptor agonist, was granted FDA approval in May for the treatment of adults with type 2 diabetes (T2D) based on data from the phase 3 SURPASS clinical trial program. Those findings showed that tirzepatide at 5 mg, 10 mg, and 15 mg significantly reduced HbA1c for adults with T2D and did not significantly increase the risk of hypoglycemia.

Lilly plans to initiate a rolling submission of a new drug application fir tirzepatide in adults with obesity and overweight later this year, according to the company.

“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 of Lilly Diabetes, in a press release. “Obesity is a chronic disease that impacts the health of nearly 100 million Americans and is a significant driver of health care costs. While diet and exercise are important steps, most patients don't achieve their desired treatment goals with only diet and exercise.”

Fast track designation from the FDA is designed to facilitate the development and expedite the review of medications for serious conditions with unmet medical need. The review of tirzepatide will be based on results from the completed SURMOUNT-1 trial and the ongoing SURMOUNT-2 trial.

Data from SURMOUNT-1, which were presented at the 82nd Scientific Sessions of the American Diabetes Association Scientific Sessions in June, showed that persons with overweight or obesity and without diabetes taking tirzepatide lost up to 22.5% of their baseline body weight. In addition, researchers observed at least 20% weight loss for more than half (57%) of participants receiving tirzepatide 15 mg, the highest dose.

SURMOUNT-2 is comparing the efficacy and safety of tirzepatide 10 mg and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased exercise in adults with T2D with obesity or overweight with coprimary objectives to demonstrate that either/both doses are superior to placebo in percentage of body weight change and in the percentage of participants losing ≥5% body weight. Results from SURMOUNT-2 are expected to be released by the end of April 2023, according to Eli Lilly.

“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,” continued Mason. “Tirzepatide also helped nearly two-thirds of participants on the highest dose reduce their body weight by at least 20 percent in SURMOUNT-1.”