GSK files albiglutide in EU
pharmafile | March 8, 2013 | News story | Research and Development |
GlaxoSmithKline has filed its investigational, long-acting diabetes drug albiglutide with the European Medicines Agency.
The GLP-1 receptor agonist, which will take the brand name Eperzan if approved, is intended as a rival to Lilly’s once-weekly injectable GLP-1 agonist Bydureon (exenatide) – a long-acting form of Byetta.
Albiglutide is also given once-weekly and is part of a relatively new class of injectable drugs designed to help patients reduce blood sugar levels (HbA1c) after they have failed on oral treatments and short and long-acting insulin products.
GSK has already announced the submission of a regulatory application in the US for the product, although its progress in trials has not been as smooth as the manufacturer would have hoped.
Last year it insisted things were on course despite disappointing data from a head-to-head trial with Novo Nordisk’s own once-daily GLP-1 analogue Victoza (liraglutide).
Harmony 7 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.
While albiglutide did demonstrate a statistically significant reduction in HbA1c from baseline, it did not meet the primary endpoint of non-inferiority to Novo’s drug.
Harmony 6 compared albiglutide to preprandial insulin, each administered on top of long-acting insulin glargine.
It showed a reduction in HbA1c from baseline of 0.82% in the albiglutide arm, compared to 0.66% for patients on preprandial lispro insulin.
Weight change from baseline was -0.73kg for patients taking albiglutide and +0.81kg in the other arm.
Other phase III studies were due to finish early this year, making them the first to look at the effects of a GLP-1 agonist over three years.
Victoza has already been approved by European and US regulators in combination with oral diabetes treatments metformin and sulphonylurea, or with glitazones such as Takeda’s Actos.
But GSK has always been adamant that albiglutide will follow suit, and this year’s filings in Europe and the US demonstrate its confidence.
GLP-1 is a peptide normally secreted from the gastrointestinal tract during eating: this helps release insulin to control blood sugar elevations after finishing a meal.
In people with type 2 diabetes, this secretion is reduced or absent.
Albiglutide has been developed to last longer because it is made up of two copies of modified human GLP-1 fused in series to human albumin.
