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UK regulators have granted marketing authorisation to tirzepatide, a first-of-its-kind in the treatment of adults with type 2 diabetes.
The once-weekly drug is a dual receptor agonist that acts on both glucose-dependent insulinotropic polypeptide (GIP) receptors and glucagon-like peptide-1 (GLP-1) receptors.
It is the first of its kind to be approved by the Medicines and Healthcare products Regulatory Agency and will be evaluated by NICE as monotherapy and with other antidiabetic agents early next year.
This authorisation is based on data from five global randomised controlled phase 3 studies involving 6,263 treated with type 2 diabetes and different doses of the drug on its own or with other treatments including including metformin, SGLT2 inhibitors, sulphonylureas and insulin glargine.
The research found tirzepatide was associated with sustained, statistically significant and clinically meaningful reductions in HbA1c compared to either placebo or active control treatment for up to one year.
Statistically significant and clinically meaningful reductions from baseline in body weight were also reported by manufacturer Eli Lilly.
Dr Patrick Holmes, a GP in Darlington and committee member of the Primary Care Diabetes Society (PCDS) said it was exciting news.
‘Tirzepatide has demonstrated unprecedented reductions in glucose levels and weight in large clinical trials.’
He added although this was the first dual treatment to be approved adding GIP activity in addition to GLP-1 agonism, many prescribers would be familiar with the approach.
‘The dual incretins therapies are the next step forward in terms of treatment for type 2 diabetes, and in time obesity.’
But he added there were questions about when this would become available for UK prescribers as there is a global shortage of the device the drug comes in that would probably last a year.
‘Hopefully this can be addressed, because only then will it be available to help people with type 2 diabetes in this country.
‘I hear Lilly is building a new factory in North Carolina to meet demand,’ he said, noting that in the US tirzepatide is also licensed for obesity.
It comes as GPs have been advised to start no new prescriptions for two key injectable GLP-1 receptor agonists amidst a global shortage.
The PCDS said it had recently been made aware of shortages of Ozempic (semaglutide) and Trulicity (dulaglutide) in the UK due to manufacturers being unable to keep up with global demand.
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