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 levels 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. Last year, the company recorded $9 billion in diabetes drug sales.
Mounjaro works by stimulating two hormones, called GLP-1 and GIP, which control the production of insulin. In clinical tests, the drug outperformed several other diabetes drugs, including one made by rival drugmaker Novo Nordisk that only acts on one hormone. Mounjaro was also better at controlling blood sugar than two guys on insulin.
“Given the difficulty many patients face in reaching their blood glucose goals, today’s approval of Mounjaro is a significant step forward in the treatment of type 2 diabetes,” said Patrick Archdeacon, Associate Director of the Diabetes Division. at the FDA’s Center for Drug Evaluation and Research. , in a report.
Like Trulicity and other drugs in its class, the most common side effects of Mounjaro are nausea, vomiting, diarrhea, and other gastrointestinal issues. The company did not announce Mounjaro’s price and did not respond to questions from BioPharma Dive per post.
The drug’s approval will intensify competition between Lilly and Novo, which have fought for market share in the United States for years. Novo, for example, recently had success launching a similar once-a-week dose of Lilly’s top-selling drug, Trulicity, as well as a daily pill that works in the same way.
Novo is testing a dual-action competitor to tirzepatide, but it’s only in Phase 2 testing, well behind Lilly’s drug. The two companies are also trying to develop a once-a-week insulin injection, with similar programs in phase 3 development.
The next frontier for both companies is obesity, where they strive to prove the value of their drugs as weight loss treatments. Novo has already won approval for a drug called Wegovy, while Lilly reported promising data for Mounjaro last month.