Eli Lilly’s Mounjaro receives FDA approval to reduce cardiovascular risks

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events, such as heart attack, stroke, and cardiovascular death, in adults with type 2 diabetes who are at high risk. This marks the first label expansion for the medication since its initial approval four years ago.

The decision follows the phase 3 SURPASS-CVOT study, which involved approximately 13,000 patients across 30 countries. In a head-to-head trial, Mounjaro demonstrated an 8% lower rate of major adverse cardiovascular events compared to Lilly’s older diabetes treatment, Trulicity.

Beyond cardiovascular benefits, Eli Lilly is exploring further applications for tirzepatide. Recent phase 3b clinical trial results indicated that combining tirzepatide with the immunosuppressant Taltz may provide significant benefits for patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis who are also obese. In these studies, patients using the combination therapy achieved higher rates of skin clearance and weight loss compared to those using Taltz alone.