Lilly drug receives FDA Fast Track designation
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Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has received Fast Track designation from the U.S. Food and Drug Administration for tirzepatide, a drug being developed to treat obesity. Lilly says the designation will help expedite the process and accelerate the drug’s path to FDA submission.
The Fast Track designation is specifically intended to facilitate development and speed up the review of medicines to treat serious conditions and fill an unmet medical need.
“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. “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.”
Lilly plans to begin a rolling submission of a new drug application for tirzepatide this year, which allows the company to submit sections of the application as they are completed instead of waiting until all sections are completed. The results will be based on two Phase 3 clinical trials, which include the already completed SURMOUNT-1, and SURMOUNT-2, which is expected to be complete by April.
Lilly says clinical trials for tirzepatide began in 2019 and have enrolled more than 5,000 people with obesity or who are overweight across six clinical trials. Results from SURMOUNT-2 are expected to be available next year.