Eli Lilly’s next-generation weight-loss shot clears another hurdle
Eli Lilly & Co.’s highly anticipated next-generation weight-loss shot didn’t increase overall heart risk in a new study, the company said, helping dispel lingering concerns
Eli Lilly & Co.’s highly anticipated next-generation weight-loss shot didn’t increase overall heart risk in a new study, the company said, helping dispel lingering concerns over its potential as it nears regulatory review. Lilly’s trial evaluated retatrutide’s cardiovascular safety in people with obesity and heart disease after earlier studies raised questions about a possible increase in heart rhythm abnormalities. The latest findings — plus another new study in patients with obesity and diabetes — help solidify the drug’s blockbuster potential. However, Lilly will seek approval from US regulators later than investors hoped. The company said Thursday that it plans to file for US Food and Drug Administration approval early next year. Some Wall Street analysts expected a filing by the end of 2026. Lilly’s shares were down less than 1% before markets opened in New York. The delay stems, in part, from the fact that Lilly is planning to submit retatrutide under an approval pathway known as a Biologics License Application, which is typically used for products like vaccines and gene therapies.
There are more complex requirements needed for a BLA, which Lilly said it’s working to complete. If the FDA ends up approving retatrutide as a biologic medicine, it would have a longer runway before being subject to government price cuts and a stronger defense against would-be copycats. Lilly’s weight-loss shot Zepbound is the most popular weight-loss medication on the market today, but the company is developing alternatives that are more effective, easier to take or offer benefits like fewer side effects. Retatrutide is a critical part of maintaining its lead over rival Novo Nordisk A/S in the highly competitive market for next-generation weight-loss drugs. The experimental shot works by combining three different gut hormones — GLP-1, GIP and glucagon — giving it an edge over other treatments. Also Read | OpenAI models escaped and hacked a company in cybersecurity test gone wrong Lilly Chief Scientific and Product Officer reacts “If approved, retatrutide would be a first: the first triple agonist, a medicine that acts on three pathways at once,” said Lilly Chief Scientific and Product Officer Daniel Skovronsky.
“In practice, that means more room for physicians and patients to find an approach that fits each person.” The latest results cement retatrutide’s “best-in-class” potential, analysts said. However, the data left some wondering about the drug’s ability to actually reduce heart attacks and strokes — a benefit seen with other weight-loss medications. Lilly is running a separate trial designed to test whether retatrutide can improve heart outcomes. “These data read positively for retatrutide’s efficacy and overall benefit-risk profile, although the limited cardiovascular event dataset could raise some questions” ahead of the heart outcomes study, BMO Capital Markets analyst Evan Seigerman said in a note. Lilly has been fighting for years to get retatrutide classified as a biologic drug. There’s potentially billions of dollars at stake for the company: In studies, retatrutide has proven to be more powerful than any other weight-loss drug on the market, with analysts expecting almost $16 billion in sales by 2036. Already, people have been clamoring to get their hands on black-market versions of the shot.
The BriefWire