Europe grants Eperzan licence
pharmafile | March 27, 2014 | News story | Sales and Marketing | Bydureon, GSK, diabetes, eperzan, lilly
The European Commission has granted marketing authorisation to GlaxoSmithKline’s new diabetes treatment Eperzan – setting the manufacturer on a collision course with Eli Lilly’s Bydureon (exenatide).
Both GLP-1 agonists are once-weekly injections and are in a relatively new class of drugs designed to help patients reduce blood sugar levels (HbA1c), after they have failed on oral treatments and short and long-acting insulin products.
Eperzan (albiglutide) is indicated for the treatment of type 2 diabetes mellitus in adults as monotherapy, when diet and exercise do not provide adequate glycaemic control for patients who cannot use metformin.
It can also be used as add-on combination therapy, with other glucose-lowering products such as basal insulin.
GSK is still waiting for a verdict in the US after the Food and Drug Administration extended its decision time by three months, and now expects to announce whether it sees the green light or not on 15 April.
GSK filed albiglutide in the US in January 2013 and with the European Medicines Agency in March – it says it wants to launch in several countries in Europe in the third quarter of the year, with more to follow.
The European decision is based on the results of the Harmony programme, which comprised eight Phase III studies with more than 5,000 patients. It pitched albiglutide against type 2 diabetes treatments such as insulin in patients at different stages of the disease, as well as those with renal impairment.
GSK overcame disappointing data from a head-to-head trial with Novo Nordisk’s own once-daily GLP-1 analogue Victoza (liraglutide) in Harmony 7.
This showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a higher reduction of 0.99% for those in the Victoza arm, meaning GSK’s drug could not prove it was as good as Victoza.
However, GSK will be pleased with the EC’s decision, even if Eperzan has not had as smooth a path to market as the firm would have hoped.
“Diabetes treatment can be challenging for healthcare professionals and patients, often involving complex daily regimens, with almost 50% of patients failing to meet their blood glucose targets,” said Vlad Hogenhuis, head of GSK’s global cardiovascular, metabolic and neurosciences franchise.
“The authorisation of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well tolerated,” he added.
Adam Hill
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