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MHRA authorises Eli Lilly’s weight management treatment  

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Eli Lilly’s TIRZEPATIDE®▼ (MOUNJARO) a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist, for weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in adults with an initial BMI of:

≥ 30 kg/m2 (obesity) or
≥ 27 kg/m2 to < 30kg/m2 (overweight) in the presence of at least one weight-related co-morbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes)1.

Tirzepatide is the first GIP and GLP-1 receptor agonist to receive MHRA marketing authorisation for weight management in adults in Great Britain. Tirzepatide currently has marketing authorisation in Great Britain for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.

This authorisation is based on results from the phase 3 SURMOUNT-1 and SURMOUNT-2 clinical trials, which both met their co-primary endpoints of demonstrating that tirzepatide 10mg and 15mg achieved superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo3.

Professor Rachel Batterham, Senior Vice President for International Medical Affairs at Lilly said: “Obesity is a complex, chronic disease that significantly negatively impacts people’s health, quality of life and life expectancy. Tackling obesity requires a holistic approach including prevention strategies, and for those already affected by obesity, clinical services and effective treatment options. We’re delighted that tirzepatide has been authorised in Great Britain. Tirzepatide is a new class of medication that can offer eligible people living with obesity another treatment option and potentially reduce the economic impact of obesity, which is estimated to cost the NHS £6.1 billion annually2.”

References

1 Summary of Product Characteristics available from UKMedInfo@lilly.com

2 Department for Health and Social Care (2020). Tackling obesity: empowering adults and children to live healthier lives. Policy paper. Available from: https://www.gov.uk/government/publications/tackling-obesity-government-strategy/tackling-obesity-empowering-adults-and-children-to-live-healthier-lives#fn:16 [Accessed October 2023]

3 le Roux, C., Zhang, S., Aronne, L. et. al. Tirzepatide for the Treatment of Obesity: Rationale and Design of the SURMOUNT Clinical Development Program 2022. Obesity; doi: 10.1002/oby.23612

 

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