Tuesday, April 16, 2024

MHRA Grants Authorization to Mounjaro for Weight Control Solutions

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The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has given its authorization for the usage of Mounjaro, known as tirzepatide, in adults aged 18 and over for managing weight control effectively. This approval extends to adults with a BMI of 30kg/m² or more (classified as obese) and those with a BMI between 27-30kg/m² (classified as overweight) who also suffer from weight-related health concerns such as prediabetes, high blood pressure, high cholesterol, or heart problems.

To optimize its efficacy, the medication should be used in conjunction with a reduced-calorie diet and increased physical activity, as stated by the MHRA. Administered through pre-filled injection pens containing varying doses of tirzepatide (ranging from 2.5mg to 15mg), the treatment involves subcutaneous injections in the stomach area, thigh, or upper arm.

MHRA’s Safety Oversight for Mounjaro in Weight Control

Tirzepatide functions by modulating a patient’s appetite, thereby reducing hunger pangs and food cravings. Julian Beach, MHRA Interim Executive Director for Healthcare Quality and Access, emphasized the prioritization of assessing this new indication for Mounjaro, recognizing the critical need for innovative medications to address obesity. He emphasized the agency’s commitment to closely monitoring the safety of Mounjaro, drawing on advice from the independent Commission on Human Medicines.

The approval of Mounjaro (tirzepatide) for weight control was based on findings from two international clinical trials—SURMOUNT-1 and SURMOUNT-2—both of which were randomized, double-blind, and placebo-controlled studies.

In SURMOUNT-1, involving 2,539 obese or overweight adults with weight-related complications (other than diabetes), participants received weekly doses of 5mg, 10mg, or 15mg tirzepatide or a placebo over 72 weeks. The trial demonstrated substantial weight loss among those treated with tirzepatide, with an average percentage change in weight of -16.0 percent (5mg dose), -21.4 percent (10mg dose), -22.5 percent (15mg dose), and -2.4 percent for the placebo. Additionally, approximately 90 percent of tirzepatide users shed at least 5 percent of their body weight, compared to only 28 percent in the placebo group.

Weight Control

SURMOUNT-2 Trial Results in Type 2 Diabetic Adults with Tirzepatide

SURMOUNT-2 comprised 938 obese or overweight adults with Type 2 diabetes, who received tirzepatide injections or a placebo over the same 72-week period. The mean percentage change in weight was -13.4 percent (10mg dose), -15.7 percent (15mg dose), and -3.3 percent for the placebo. Notably, 81.6 percent (10mg) and 86.4 percent (15mg) of tirzepatide recipients lost at least 5 percent of their body weight, contrasting with 30.6 percent in the placebo group.

These significant findings from clinical trials support the MHRA’s decision to authorize tirzepatide for weight control, showcasing its potential as a promising intervention in combating obesity and related health complications.

 

Resource: European Pharmaceutical Review, December 08, 2023

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