Eli Lilly targets FDA approval for weight loss medication
Drugmaker Eli Lilly is looking for FDA approval of its obesity medication after recent trial results showed positive results for weight loss.
Eli Lilly’s diabetes drug tirzepatide, sold under the name Mounjaro, was approved by the U.S. Food and Drug Administration (FDA) for diabetes treatment, but the pharma company will seek approval for obesity treatment as well with high-dose tirzepatide.
Mounjaro is among a handful of drugs with big buzz for their weight loss results, and approval for obesity could be a huge revenue source for Eli Lilly in the future.
The company’s latest trial found that tirzepatide (10 mg and 15 mg) achieved superior weight loss compared to placebo at 72 weeks of treatment. The trial, SURMOUNT-2, included 938 adult participants with obesity or overweight and type 2 diabetes. Those taking tirzepatide lost up to 15.7% (34.4 lb) of body weight during the trial period.
"Obesity is a difficult-to-manage disease, and it's even more difficult for people living with type 2 diabetes," Jeff Emmick, MD, PhD, senior vice president, product development, Lilly, said in a statement. "The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes."
Participants taking tirzepatide achieved average weight reductions of 13.4% (29.8 lb.) on the lower dose of 10 mg and 15.7% (34.4 lb.) on the higher dose of 15 mg, compared to a placebo group. In addition, 81.6% (10 mg) and 86.4% (15 mg) of people taking tirzepatide achieved at least 5% body weight reduction, the other co-primary endpoint, compared to 30.5% of those taking placebo.
Based on these results, Eli Lilly plans to complete the U.S. submission for tirzepatide in adults with obesity or overweight with weight-related comorbidities in the coming weeks, with regulatory action expected by late 2023. The pharma company will also present the trial findings at the American Diabetes Association's 83rd Scientific Sessions and submit the results to peer-reviewed journals.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."