Eli Lilly’s tirzepatide injection has been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) for weight loss and weight management in individuals aged 18 years and over.
Both regulators have authorised the dual GIP/GLP-1 agonist, sold under the brand name Mounjaro or Zepbound, for use alongside a reduced-calorie diet and increased physical activity in adults with a BMI of 30 or more, as well as those with a BMI of 27 or more and at least one weight-related health problem such as pre-diabetes, high blood pressure or high cholesterol.
Tirzepatide, which is currently used to treat type 2 diabetes, will be available for weight management as a pre-filled pen to be injected under the skin of a patient’s stomach area, thigh or upper arm.
The new indications are supported by the results of two late-stage trials, which demonstrated that obese or overweight patients with and without diabetes who were treated with tirzepatide had a significant weight loss over time compared to those receiving placebo.
Dr Leonard Glass, senior vice president global medical affairs, Lilly Diabetes and Obesity, said: “For decades, diet and exercise have been a go-to, but it’s not uncommon for a person to have tried 20 to 30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult.
“Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
Tirzepatide is expected to be available in the US by the end of the year, Lilly said, but the therapy must now be reviewed by the National Institute for Health and Care Excellence before it is recommended for use on the NHS.
The UK health and social care secretary, Steve Barclay, said in a statement: “Although further approvals are needed to use this in the NHS, [tirzepatide] has the potential to help thousands of people living with obesity and support those suffering from weight-related illnesses – if used alongside diet and physical activity.”
The approvals come under two months after Lilly said it was suing ten medical spas, wellness centres and compounding pharmacies to stop the “unlawful marketing” and sales of products fraudulently claiming to be tirzepatide.