CHMP positive for Mounjaro (tirzepatide) for the treatment of obesity

The recommendation comes the same week the drug was approved for obesity treatment in the US.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mounjaro. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V. The CHMP adopted an extension to the existing indication to include weight management.

The indication is : Weight management; Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of greater than 30 kg/m2 (obesity) or greater than 27 kg/m2 to les than 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).