A new weight loss jab will be available in Britain within weeks after it is approved by the medicines regulator.
Mounjaro, also known as tirzepatide, can be used to treat obesity or type 2 diabetes, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
The drug was developed by US pharmaceutical company Eli Lilly and studies show that those given the highest dose lost an average of more than three stones.
It is injected under the skin of the stomach, thigh or upper arm.
The drug itself was approved for use in November last year, but was not yet available in Britain due to huge global demand.
After losing weight by changing their lifestyle and then using the shot, users lost an average of 24.3 percent of their starting body weight
According to the latest data, digestive problems were the most commonly reported side effects of tirzepatide, Mounjaro’s active ingredient. About one in five participants suffered from nausea and diarrhea, and about one in ten reported vomiting or diarrhea
But the MHRA has now become the first regulator in the world to approve a new device for delivering the drug, which Eli Lilly said will allow them to supply the UK ‘within weeks’.
The new jab comes in a four-dose pen, branded KwikPen, which provides a month’s worth of treatment when used once a week.
It was previously only available in single doses.
Laura Steele, president and managing director of UK and Northern Europe at Lilly, said: ‘The MHRA is the first major regulator in the world to grant a marketing authorization for the KwikPen alternative presentation to tirzepatide, which demonstrates their clear focus on accelerating innovation to help patients. .
“This will allow Lilly to start delivering to Great Britain within weeks.”
Mounjaro KwikPen is approved for the treatment of adults with type 2 diabetes and for weight management in obese adults, as well as for overweight adult patients who have weight-related health problems such as prediabetes, high blood pressure, high cholesterol or heart problems.
Mounjaro will offer an alternative to the weight loss drug Wegovy – also known as semaglutide – which is also in short supply due to overwhelming demand.
Julian Beach, interim director of quality and access to healthcare at the MHRA, 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 clearly.
‘This approval allows access to the approved Mounjaro pen in a more convenient format for a one-month treatment of one dose per week.’
The drugs watchdog NThe jab was given the green light for use by the NHS in September last year by the National Institute for Health and Care Excellence (Nice) – the drugs watchdog – approved the jab for use in the NHS in September, but only for patients with type 2 diabetes patients who do not have the disease under control.
Some Americans are already using it ‘off label’. One of them is Matthew Barlow, a 48-year-old health technology executive living in California, who said he has lost more than 50 pounds since November 2022 by taking Mounjaro and changing his diet.
It has yet to be given the green light for use by the NHS to treat obesity, but can be bought privately.
The active ingredient in the drug helps lower sugar levels in people with type 2 diabetes when their levels are high, and acts as a weight management drug by making a patient feel full and less hungry, and making him eat less experience cravings for food.
The latest authorization from the MHRA is based on the results of a bridging study which showed that the efficacy and safety of the multi-dose Mounjaro KwikPen is expected to be the same as the single-use pen.
Douglas Twenefour, head of care at Diabetes UK, said: ‘We hope that the approval of this device by the MHRA will help eligible people with type 2 diabetes to access this effective treatment.
‘Supporting people with type 2 diabetes to lose weight and control 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 do this reach.’
The MHRA warned that the drug could affect how well the contraceptive pill works in obese or overweight female patients.
It also listed possible side effects of the drug, including nausea, diarrhea, vomiting — which usually goes away with time — and constipation.
Low blood sugar is also “very common” in patients with diabetes, the agency added.
The MHRA said it will closely monitor the safety and effectiveness of Mounjaro.