Eli Lilly’s diabetes medication Mounjaro receives expanded FDA approval to reduce major cardiovascular events, strengthening its position in the incretin-based treatment market amid new clinical evidence.
Eli Lilly shares nudged higher in pre-market trading on Friday after the US Food and Drug Administration broadened the label for Mounjaro, giving the diabetes drug an approved role in cutting the risk of major cardiovascular events in certain adults with type 2 diabetes. The move adds a fresh commercial and clinical boost to a medicine already used for blood sugar control, and it strengthens Lilly’s position in the fast-growing market for incretin-based treatments.
According to the FDA and Lilly, the expanded approval covers adults with type 2 diabetes who are at increased cardiovascular risk and allows Mounjaro to be prescribed to reduce the chance of cardiovascular death, non-fatal heart attack and non-fatal stroke. The drug, whose active ingredient is tirzepatide, is already marketed in the US for type 2 diabetes, while the same molecule is sold as Zepbound for chronic weight management.
The FDA’s decision was based on the SURPASS-CVOT study, a large cardiovascular outcomes trial that enrolled 13,299 people across 640 sites in 30 countries. Lilly said the medicine met the study’s main goal by matching Trulicity on major cardiovascular outcomes, while Reuters reported that the treatment showed an 8% lower rate of cardiovascular death, heart attack or stroke in the population studied. The trial’s findings did not establish clear superiority, but they were sufficient for the agency to add the cardiovascular claim.
Lilly said the safety profile seen in SURPASS-CVOT was broadly in line with earlier studies, with stomach-related side effects remaining the most common and usually appearing as doses were increased. The drug still carries warnings about thyroid tumours, pancreatitis, low blood sugar, kidney problems, severe allergic reactions, gallbladder disease and certain surgical risks. The new approval puts Mounjaro in closer competition with other drugs in the same class, including Wegovy, which the FDA approved in 2024 to lower cardiovascular risk in adults with obesity or overweight who also have heart disease.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
