Weight loss drug approved in four-dose injection pen format by MHRA
A weight loss drug has been approved in a four-dose injection pen format (Chris Radburn/PA)
A weight loss drug has been approved in a four-dose injection pen format by the Medicines and Healthcare products Regulatory Agency (MHRA).
Mounjaro, also known as tirzepatide, is a diabetes drug that was authorised by the MHRA to help obese and overweight adults with weight management and loss in November last year.
The authorisation of US pharmaceutical company Eli Lilly’s Mounjaro “KwikPen” means the company will be able to “begin supply to the UK within weeks”, according to president and general manager of UK and northern Europe at Lilly, Laura Steele, as reported in the Guardian.
Mounjaro KwikPen gives four doses of the drug for once-a-week treatment over a month, and has been approved to treat adults with type 2 diabetes and for weight management in obese adults, as well as overweight adult patients who have weight-related health problems like prediabetes, high blood pressure, high cholesterol, or heart problems.
Julian Beach, MHRA interim executive director of 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.”
The jab was given the green light for NHS use in September last year by the National Institute for Health and Care Excellence (Nice) as an option for patients with type 2 diabetes who do not have the condition under control, but Nice has yet to approve the use of the drug in the NHS for obesity.
The active ingredient in the drug helps to reduce sugar levels in people with type 2 diabetes when their levels are high, and works as a weight management drug by making a patient feel full and less hungry, and making them experience fewer food cravings.
The MHRA’s newest authorisation is based on the results of a bridging study which showed the efficacy and safety of the multidose Mounjaro KwikPen are expected to be the same as those for the single-dose pen.
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.”
The MHRA warned the drug may affect how well the contraceptive pill works in obese or overweight female patients.
It also listed potential side effects of the medicine, including nausea, diarrhoea, vomiting – which usually goes away over time – and constipation.
Low blood sugar is also “very common” in patients with diabetes, the agency added.
The MHRA said it will keep the safety and effectiveness of Mounjaro under close review.