Medicines Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (8 November 2023) authorised via a national application route, a new indication for the diabetes medicine, Mounjaro (tirzepatide), for weight loss and weight management in adults aged 18 and over.
Mounjaro is now authorised for adult patients with a BMI of 30kg/m or more (obesity), as well as those with a BMI between 27-30kg/m (overweight) who also have weight-related health problems such as prediabetes, high blood pressure, high cholesterol, or heart problems.
The medicine is to be used together with a reduced-calorie diet and increased physical activity.
The active ingredient in this treatment, tirzepatide, works by regulating a patients appetite so they feel full, making them feel less hungry and experience fewer food cravings.
Mounjaro is available for weight management as a pre-filled injection pen filled with 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg of tirzepatide, injected under the skin of a patients stomach area, thigh or upper arm.
The starting dose is 2.5mg once a week for four weeks, increasing to 5mg once a week. The dose may then be increased in at least 4-week intervals up to the maximum dose of 15mg once weekly, if recommended by the patients doctor.
Obese or overweight female patients using oral contraceptives should consider also using a barrier method of contraception (e.g., a condom) or switching to a non-oral contraceptive method for 4 weeks after starting Mounjaro and for 4 weeks after each increase in dose as Mounjaro may affect how well the contraceptive pill works in these patients.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
We have prioritised rapid assessment of this new indication for Mounjaro, given the public health importance of access to new medicines to help tackle obesity.
We have drawn on advice from the independent Commission on Human Medicines in coming to our decision, and as with all products, will keep the safety of Mounjaro under close review.
The new weight management indication is based on the results of two international, randomised double-blind, placebo-controlled clinical trials, SURMOUNT-1 and SURMOUNT-2, in overweight and obese adult patients with and without diabetes.
The studies showed that patients who were treated with tirzepatide had a significant weight loss over time compared to patients who took a placebo.
In SURMOUNT-1, 2,539 obese or overweight adults with at least one weight-related complication (that was not diabetes) were given either weekly 5mg, 10mg or 15 mg tirzepatide, or a placebo over a 72-week period. The average percentage change in weight over the trial period was -16.0% for the 5mg dose, -21.4% for the 10mg dose, -22.5% for the 15mg dose and -2.4% for the placebo. In addition, 89.4% (5 mg), 96.2% (10 mg) and 96.3% (15 mg) of patients taking tirzepatide lost at least 5% of their body weight compared to 27.9% of those taking the placebo.
In SURMOUNT-2, 938 obese or overweight adults with Type-2 diabetes were given either weekly 10mg or 15mg tirzepatide or a placebo over a 72-week period. Mean percentage change in weight over the trial period was -13.4% for the 10mg dose, -15.7% for the 15mg dose and -3.3% for the placebo. In addition, 81.6% (10 mg) and 86.4% (15 mg) of patients taking tirzepatide lost at least 5% of their body weight compared to 30.6% of those taking the placebo.
The most common side effects of the medicine are nausea, diarrhoea, vomiting (which usually goes away over time), and constipation. Low blood sugar (hypoglycaemia) is also very common in patients with diabetes. Symptoms of this can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.
As with any medicine, the MHRA will keep the safety and effectiveness of Mounjaro under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors?
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The new indication was granted on 8 November 2023 to Eli Lilly Nederland B.V
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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For more information about the SURMOUNT studies, see the Summary of Products Characteristics.
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For more information on obesity and overweight see: Obesity - NHS (www.nhs.uk)
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.?
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The MHRA is an executive agency of the Department of Health and Social Care (DHSC).?
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020