Lilly’s game-changing weight loss drug granted FDA fast track

INDIANAPOLIS (WISH) — Eli Lilly and Co.’s new weight loss drug could be available to patients sooner than expected. 

The U.S. Food and Drug Administration granted tirzepatide a fast-track designation, which is a process designed to speed up the review of drugs designed to treat serious medical conditions to patients as soon as possible. 

The nation has been struggling with an obesity crisis for decades. Currently, 70% of Americans are considered overweight or obese putting them at risk for heart disease, stroke, Type 2 diabetes.

News 8 reported on Lilly’s phase 3 trial results in June. Researchers assigned over 2,500 overweight and obese adults into 4 groups. Participants were prescribed a weekly injection of either 5, 10, or 15 milligrams of tirzepatide. The fourth group received a placebo. 

After 72 weeks, results showed the group taking five milligrams lost 35 pounds or 16% of their body weight. The group taking 10 milligrams lost 49 pounds or 21% of their body weight. The group taking 15 milligrams lost an average of 52 pounds, which is equivalent to 22.5% of their body weight.

“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,” Mike Mason, executive vice president of Eli Lilly and Company and president of Lilly Diabetes, said in a news release. “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. We are dedicated to helping people living with obesity through our research and development of innovative treatments like tirzepatide.”