The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a four-dose version (covering a month’s 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/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.
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 people’s health, is clear.
“This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month’s treatment, of one dose per week.”
Douglas Twenefour, Head of Care at Diabetes UK, said:
“We hope the MHRA’s 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 patient’s 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 patient’s 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 patient’s 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).
