Medicines Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a four-dose version (covering a months treatment) of the diabetes and weight management medicine Mounjaro (tirzepatide) -Mounjaro KwikPen.
Mounjaro KwikPen is approved to treat adults with type 2 diabetes and for weight management in 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.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on peoples health, is clear.
This approval enables access to the approved Mounjaro pen in a more convenient presentation of a months treatment, of one dose per week.
Douglas Twenefour, Head of Care at Diabetes UK, said:
We hope the MHRAs approval of this device will help people living with type 2 diabetes, who are eligible, to access this effective treatment.
Supporting people with type 2 diabetes to lose weight and manage their blood sugar levels is key to reducing the risk of diabetes-related complications, and tirzepatide (Mounjaro) expands the range of treatment options available to help people achieve this.
Mounjaro KwikPen is available as a four-dose pre-filled injection pen containing 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg of tirzepatide per dose, injected under the skin of a patients stomach area, thigh or upper arm.
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.
How it works
The active ingredient in this treatment, tirzepatide, helps to reduce sugar levels in people with type 2 diabetes only when the levels of sugar are high.
It also regulates a patients appetite, so they feel full, making them feel less hungry and experience fewer food cravings.
Evidence base
The approval of Mounjaro Kwikpen is based on the results of a bridging study, which provided evidence that the efficacy and safety of the multidose Mounjaro Kwikpen are expected to be the same as those for the single-dose Mounjaro pen that is approved based on seven global clinical trials.
Five of these trials (SURPASS 1-5), involving 6,263 participants in total, looked at the safety and efficacy of the active ingredient tirzepatide in participants with type 2 diabetes. Across all the studies, participants who received tirzepatide showed significant decreases in fasting glucose levels compared to either placebo or an active control (semaglutide, insulin degludec and insulin glargine) for up to 1 year. In one study these effects were sustained for up to 2 years. Significant decreases in body weight were also demonstrated.
Two of these trials (SURMOUNT 1-2), involving 3,477 participants in total, looked at safety and efficacy of tirzepatide when used for weight management (reduction and maintenance) in overweight and obese adults with and without diabetes. In both studies, overweight or obese adults treated with tirzepatide saw significant reductions in body weight compared to placebo, irrespective of age, sex, race, ethnicity, baseline BMI and glycaemic (status).
Side effects
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.
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.
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
- This line extension was granted on 25 January 2024 to Eli Lilly Nederland B.V.
- 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.
- For more information about the SURPASS or SURMOUNT studies, see the Summary of Product Characteristics.
- 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.
- The MHRA is an executive agency of the Department of Health and Social Care (DHSC).
- For media enquiries, please contact thenewscentre@mhra.gov.uk, or call