MHRA authorises tirzepatide (Mounjaro) for weight management and weight loss

Tirzepatide is now approved for use in adults with a BMI of 30kg/m² or more (obesity), as well as those with a BMI between 27-30kg/m² (overweight) who also have weight-related health problems such as prediabetes, high blood pressure, high cholesterol, or heart problems.

SPS commentary:

It is advised that obese or overweight female patients using oral contraceptives should consider using a barrier method of contraception or switching to a non-oral contraceptive method for 4 weeks after starting tirzepatide and for 4 weeks after each increase in dose as it may affect efficacy of the contraceptive pill.

Tirzepatide is already licensed for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise NICE recommends tirzepatide for type 2 diabetes in adults, only if triple therapy with metformin and 2 other oral antidiabetic agents is ineffective, not tolerated, or contraindicated, and other specific weight related risk factors and patient parameters apply. NICE will be appraising tirzepatide within its marketing authorisation for managing obesity or overweight with risk factors and guidance expected in March 2024. The FDA has also approved tirzepatide for chronic weight management.

Source:

Medicines and Healthcare products Regulatory Agency

Resource links:

NICE draft scope

FDA approval