The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new class of treatment for adults with insufficiently controlled type 2 diabetes.
Marketing authorisation has been granted for Eli Lilly’s tirzepatide (Mounjaro), a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) as an adjunct to diet and exercise.
Tirzepatide is approved as monotherapy when metformin is inappropriate due to intolerance or contraindications or in addition to other medicinal products. It is the first GIP and GLP-1 receptor agonist authorised for the treatment of adults with type 2 diabetes in Great Britain.
“Living with type 2 diabetes is not easy and in practice we know that many people are not reaching their target blood glucose levels,” said Dr Matthew Capehorn, Clinical Manager and General Practitioner with Special Interest at The Rotherham NHS Foundation Trust.
“I’m delighted that tirzepatide has been authorised in Great Britain, representing a new class of type 2 diabetes medication that can provide another treatment option for eligible patients.”
The authorisation is based on data from the SURPASS Phase III global clinical development programme: five global studies involving 6263 patients.
Efficacy was evaluated for tirzepatide 5mg, 10mg and 15mg used alone or in combination with other diabetes medications, including metformin, SGLT2 inhibitors, sulphonylureas and insulin glargine.
Across all studies, treatment with tirzepatide demonstrated sustained, statistically significant and clinically meaningful reductions in HbA1c compared to either placebo or active control treatment (semaglutide 1mg, insulin degludec and insulin glargine) for up to one year. Reductions in body weight were also demonstrated.