The Food and Drug Administration on Friday approved Eli Lilly’s diabetes drug Mounjaro, a first-of-its-kind treatment that can help control patients' blood sugar and, potentially, help them lose weight as well.
Mounjaro, also known as tirzepatide, expands Lilly’s diabetes business, which includes insulins as well as other types of therapies. The company recorded $9 billion in diabetes drugs sales last year.
Mounjaro works by stimulating two hormones, called GLP-1 and GIP, that control insulin production. In clinical testing, the drug outperformed several other diabetes medicines, including one made by rival drugmaker Novo Nordisk that only acts on one hormone. Mounjaro was more effective in controlling blood sugar than two types on insulin as well.
"Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes," said Patrick Archdeacon, associate director of the diabetes division in FDA’s Center for Drug Evaluation and Research, in a statement.
Like Trulicity and other drugs in its class, Mounjaro’s most common side effects are nausea, vomiting, diarrhea and other gastrointestinal problems. Lilly said it will launch the drug commercially “in coming weeks.” A spokesperson said it hasn’t announced a price for the drug yet.
The drug's approval will heighten competition between Lilly and Novo, which have battled for market share in the U.S. for years. Novo, for instance, has recently had success by launching Ozempic, a similar, once-weekly shot to Lilly's top-selling drug Trulicity, as well as a daily pill that works the same way.
While the clinical trial results supporting Mounjaro were strongly positive, advisers to the Institute for Clinical and Economic Review, an independent drug cost watchdog, found there wasn't sufficient evidence to prove Lilly's drug provides a significant health benefit over Ozempic.
Novo is testing a dual-acting competitor to Mounjaro, but it's only in Phase 2 testing, well behind Lilly's drug. Both companies are also trying to develop a once-weekly insulin shot, with similar programs in Phase 3 development.
The next frontier for both companies is in obesity, where they are working to prove their drugs' worth as weight loss treatments. Novo has already won approval for a drug called Wegovy, while Lilly reported promising data for Mounjaro last month.
Editor's note: This story has been updated to include additional detail about Lilly's launch plans as well as more background information.