Tirzepatide authorised by MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for tirzepatide, a top pharmaceutical company has announced.
Eli Lilly and Company has received authorisation for its once-weekly GIP receptor and GLP-1 receptor agonist for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.
Tirzepatide is the first GIP and GLP-1 receptor agonist authorised for the treatment of adults with type 2 diabetes in Great Britain.
Dr Matthew Capehorn, Clinical Manager and General Practitioner with Special Interest at The Rotherham NHS Foundation Trust, said: “Living with type 2 diabetes is not easy and in practice we know that many people are not reaching their target blood glucose levels.
“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 people.”
Fernando Campo, Associate Vice President – Head of Diabetes, Lilly Northern Europe, said: “Tirzepatide reflects Lilly’s unwavering commitment to delivering innovative solutions for eligible people with type 2 diabetes, we are thrilled by this decision.
“As a leader in diabetes care, Lilly is proud to be researching and advancing diabetes treatment to help meet the needs of people with type 2 diabetes.”
This authorisation is based on data from the SURPASS phase 3 global clinical development programme.
The safety and efficacy of tirzepatide was evaluated in five global randomised, controlled, phase 3 studies (SURPASS 1-5) involving 6,263 treated 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 commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulphonylureas and insulin glargine.
The primary endpoint in all SURPASS studies was reduction in HbA1c from baseline. Secondary endpoints included mean change in body weight, fasting serum glucose and proportion of people reaching target HbA1c.
Across all studies, treatment with tirzepatide demonstrated sustained, statistically significant and clinically meaningful reductions from baseline in HbA1c as the primary objective compared to either placebo or active control treatment (semaglutide 1 mg, insulin degludec and insulin glargine) for up to one year.
Statistically significant and clinically meaningful reductions from baseline in body weight were also demonstrated.
Results from the phase 3 studies are presented below based on the on-treatment data without rescue therapy in the modified intent-to-treat (mITT) population consisting of all randomly assigned people exposed to at least one dose of study treatment, excluding those discontinuing treatment due to inadvertent enrolment.