Lilly to file for next-gen obesity drug approval in early 2027
Investing.com -- Eli Lilly announced Thursday it will file for approval of its next-generation obesity drug retatrutide in the first quarter of 2027, pushing back from an earlier timeline that targeted this year. The pharmaceutical company said it needs additional time to collect and verify manufacturing and quality-control data required by regulators.
The weekly injection succeeded in two additional Phase 3 trials, showing weight loss and improvements in blood sugar levels in adults with obesity and related complications. In one trial, adults with obesity and Type 2 diabetes lost up to an average of 20.8% of their weight, or nearly 50 pounds, at 80 weeks. In another trial, adults with severe obesity and established cardiovascular disease lost up to an average of 22.6% of their weight, or 55.8 pounds, at 80 weeks.
Kenneth Custer, president of Lilly Cardiometabolic Health, said the company believes it has the information necessary to file for approval globally for retatrutide as a potential treatment for obesity, knee osteoarthritis pain and obstructive sleep apnea.
The drug targets GLP-1, GIP and glucagon hormones, unlike existing treatments that target one or two of these hormones. Tirzepatide, the active ingredient in Lilly's Zepbound, mimics GLP-1 and GIP, while Novo Nordisk's semaglutide in Wegovy mimics only GLP-1.
Common side effects included diarrhea, nausea and constipation, consistent with previous studies and the broader GLP-1 class.
TD Cowen analysts estimated in January that retatrutide could generate sales of $3.8 billion in 2030. The drug represents the next pillar of Lilly's obesity portfolio after Zepbound and its newly launched pill Foundayo.
Earlier this week, Novo Nordisk filed a lawsuit against Lilly in U.S. District Court in New Jersey, alleging false advertising regarding the performance of Lilly's weight-loss medications compared to Novo's products.
