An expert panel of the EU drug regulator, the European Medicines Agency (EMA), declined on Friday to endorse heart failure as a new indication for Mounjaro (tirzepatide), Eli Lilly’s (LLY) blockbuster diabetes/obesity drug.
The GIP/GLP-1 dual receptor agonist is currently used along with diet and physical activity in the EU for weight management in obese or overweight people with weight-related health conditions.
The Indiana-based drugmaker has sought a label expansion for the injectable to treat obese adults showing evidence of chronic heart failure with preserved ejection fraction (HFpEF).
“EMA did not recommend that a separate indication should be granted for the treatment of HFpEF,” the regulator said following a review by its Committee for Medicinal Products for Human Use (CHMP).
However, it agreed to update the Mounjaro label to include relevant data supporting the company’s marketing application for the HFpEF indication.