A new weight-loss injection will be available in the UK within weeks to treat thousands of patients with type 2 diabetes or obesity, after the medicines watchdog became the first major regulator in the world to green-light the drug in a more convenient device light.
Mounjaro was developed by the American pharmaceutical company Eli Lilly. Trials show it helps those on the highest dose lose an average of more than three stone. It is injected under the skin of a patient’s stomach area, thigh, or upper arm and must be used in conjunction with a reduced-calorie diet and increased physical activity.
The drug itself, also known as tirzepatide, won approval for obesity and type 2 diabetes from the Medicines and Healthcare Products Regulatory Agency (MHRA) late last year, but it was not yet available due to enormous global demand.
The watchdog has approved a new device for delivering the drug – a four-dose pen branded as KwikPen, which covers a month’s treatment – which Eli Lilly says will allow it to deliver the drug to the UK within weeks supply.
The development, announced by the MHRA on Thursday, means there will be an alternative to the weight loss drug Wegovy, also known as semaglutide, which is manufactured by the Danish company Novo Nordisk. It was given to tens of thousands of patients on the NHS, but global shortages meant it was only available to a fraction of those eligible to take it.
Julian Beach, the MHRA’s 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 gives access to the approved Mounjaro pen in a more convenient presentation of a month’s treatment, of one dose per week.”
Eli Lilly said the green light for the more convenient device, which contains four doses instead of one, would allow the company to roll out the drug almost immediately.
“The MHRA is the first major regulator in the world to issue marketing authorization for the alternative KwikPen offering to tirzepatide, demonstrating their clear focus on accelerating innovation to help patients,” said Laura Steele, president and general manager of the UK and Northern Europe at Lilly. “This will enable Lilly to start supplying the UK within weeks.”
The MHRA has approved Mounjaro for patients with type 2 diabetes and patients with obesity. The drug has also been approved by the National Institute for Health and Care Excellence for use in the NHS for type 2 diabetes and is awaiting approval for obesity.
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Douglas Twenefour, the head of care at Diabetes UK, said: “We hope that the MHRA’s approval of this device will help eligible people living with type 2 diabetes 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 it.”
The MHRA said that Mounjaro can be used to treat adults with type 2 diabetes and obese patients with a body mass index higher than 30. It will also be offered to some overweight patients with a BMI of between 27 and 30 if they also have a different weight. related condition such as pre-diabetes, high blood pressure, high cholesterol or heart problems.
The MHRA said the most common side effects were nausea, diarrhoea, vomiting and constipation. Low blood sugar (hypoglycaemia) was also very common in patients with type 2 diabetes, it added.
