FDA makes GSK wait
pharmafile | August 6, 2013 | News story | Sales and Marketing | FDA, GSK, albiglutide, diabetes
The FDA is making GlaxoSmithKline wait for a verdict on the manufacturer’s investigational type 2 diabetes treatment albiglutide, extending its decision time by another three months.
The US regulator has now set a US Prescription Drug User Fee Act (PDUFA) goal date of 15 April 2014 to say whether or not the long-acting, once-weekly treatment should be given the green light.
GSK filed albiglutide in the US in January this year and followed this with a marketing authorisation application to the European Medicines Agency in March.
While matters in Europe appear to be progressing to schedule, the FDA wants the extra time to allow a full review of information submitted by GSK in response to the regulator’s questions about the GLP-1 receptor agonist.
Albiglutide, which is not approved for use anywhere in the world, will take the brand name Eperzan if approved, and is intended as a rival to Lilly’s once-weekly injectable GLP-1 agonist Bydureon (exenatide) – a long-acting form of Byetta.
Albiglutide 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.
Yet while it is potentially exciting, the drug’s progress in trials has not been as smooth as GSK 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.
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.
Adam Hill
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