Eli Lilly wins Mounjaro heart risk approval

• The U.S. FDA expanded Mounjaro’s approval to reduce major cardiovascular event risk in certain adults with type 2 diabetes.
• The approval was supported by the Phase 3 SURPASS-CVOT trial involving 13,299 participants across 30 countries.
• Eli Lilly said Mounjaro showed cardiovascular non-inferiority compared with Trulicity, without demonstrating superiority.

Eli Lilly (NYSE:LLY) received U.S. FDA approval for an expanded indication of Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk.

The decision was based on the Phase 3 SURPASS-CVOT trial, which compared Mounjaro with Trulicity (dulaglutide) in 13,299 participants across 30 countries over approximately five years.

The SURPASS-CVOT trial showed Mounjaro was non-inferior to Trulicity for the composite MACE-3 endpoint, which includes cardiovascular death, non-fatal heart attack, and non-fatal stroke, while superiority was not demonstrated.

The company stated that the expanded indication adds cardiovascular risk reduction information to Mounjaro’s approved uses.

Mounjaro is a dual GIP and GLP-1 receptor agonist used in the treatment of type 2 diabetes, with Lilly reporting that the trial’s safety profile was generally consistent with previous clinical experience.

The company said the most common side effects during dose escalation were gastrointestinal events, while prescribing information includes boxed warnings and other safety information related to potential serious risks.