The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for tirzepatide, the new once-weekly glucose-dependent insulinotropic polypeptide–glucagon-like peptide-1 (GIP/GLP-1) receptor agonist.
Tirzepatide (brand name Mounjaro®; Eli Lilly & Co.) is authorised for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise:
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or
- in addition to other medicinal products for the treatment of diabetes.
The authorisation is based on data from the SURPASS phase 3 programme, which included five global clinical trials involving 6263 people with type 2 diabetes (4199 treated with tirzepatide). Efficacy was evaluated for tirzepatide 5 mg, 10 mg and 15 mg, used alone or in combination with other diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine. Across all studies in the SURPASS programme, tirzepatide demonstrated statistically significant and clinically meaningful reductions in HbA1c and body weight compared with both placebo and active comparators (the GLP-1 RA semaglutide, insulin glargine and insulin degludec).
In the modified intention-to-treat analyses at 40–52 weeks, HbA1c reductions from baseline across the SURPASS programme averaged around 25 mmol/mol (2.3%) with the 15 mg dose, while average weight reductions at this dose typically exceeded 10 kg.
Tirzepatide is the first GIP/GLP-1 receptor agonist authorised for the treatment of adults with type 2 diabetes in Great Britain. It will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg) and will come in Lilly’s auto-injector pen with a pre-attached, hidden needle that patients do not need to handle or see.
