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EMA declines new heart-risk indication for Mounjaro but adds trial data to label

Regulatory

The EMA's CHMP finished assessing an application to extend tirzepatide (Mounjaro) to reducing the risk of serious cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. The committee did not recommend the new indication but agreed to add the relevant trial data to the product information. Lilly had said it would submit data from SURPASS-CVOT, in which tirzepatide was non-inferior to dulaglutide, to regulators by the end of 2025.

Sources

  1. 01Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026(opens the source in a new tab) European Medicines Agency
  2. 02Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial(opens the source in a new tab) Eli Lilly and Company

Peptides involved

  1. ApprovedTirzepatideDual GIP and GLP-1 receptor agonist39
  2. ApprovedDulaglutideGLP-1 receptor agonist (Fc fusion protein)31