The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation for Eli Lilly’s Mounjaro (tirzepatide) for weight loss and weight management.
This approval for the new indication of the diabetes drug was executed through the agency’s national application route.
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The weight loss drug is indicated for usage in obese and overweight adults aged 18 years and above, along with a lower-calorie diet and exercise.
Only individuals with weight-linked health issues such as high blood pressure, prediabetes, high cholesterol or heart ailments are eligible to receive Mounjaro.
The latest development is based on findings from SURMOUNT-1 and SURMOUNT-2 clinical trials in overweight and obese adults irrespective of their diabetes status.
Data from the trials showed that tirzepatide offered a substantial weight loss over time versus placebo.
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By GlobalDataOffered as a pre-filled injection pen containing a 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg or 15mg dose of tirzepatide, the treatment is injected under the skin of the stomach, thigh or upper arm.
Tirzepatide acts by regulating the patients’ appetite, making them less hungry and reducing food cravings.
MHRA Healthcare Quality and Access interim executive director Julian Beach stated: “We have prioritised rapid assessment of this new indication for Mounjaro, given the public health importance of access to new medicines to help tackle obesity.
“We have drawn on advice from the Independent Commission on Human Medicines in coming to our decision, and as with all products, will keep the safety of Mounjaro under close review.”
