Mounjaro (tirzepatide) receives positive CHMP opinion for on variation to marketing authorisation for treatment of type 2 diabetes – Eli Lilly

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Mounjaro (tirzepatide).

The marketing authorisation holder is Eli Lilly Nederland B.V. The CHMP adopted an extension to an existing indication as follows: Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medications for the treatment of diabetes.

Treatment options for this group have been limited, which makes incremental approvals meaningful both clinically and commercially.