GSK diabetes drug fails head-to-head against Victoza
pharmafile | November 16, 2011 | News story | Sales and Marketing | GLP-1, Victoza, albiglutide, diabetes
GlaxoSmithKline’s long-acting diabetes drug albiglutide has failed in a head-to-head trial against Novo Nordisk’s Victoza.
Albiglutide is an injectable glucagon-like peptide-1 (GLP-1) agonist currently undergoing Phase III trials to help type II diabetes patients reduce their blood sugar levels after they have failed on oral treatments.
In the Harmony 7 study the once-weekly drug daily did not meet its primary endpoint in a non-inferiority study against once-daily Victoza (liraglutide).
Victoza is also a GLP-1 drug, and was approved by European and US regulators last year in combination with current oral diabetes treatments metformin and sulphonylurea, or with glitazones such as Takeda’s Actos.
The trial results showed a reduction in blood sugar level (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.
Despite the setback, GSK said it is still seeking regulatory approval and believes that results from Harmony 7 would ‘support progression towards registration’.
If approved the drug’s closest rival will be Lilly’s once-weekly injectable GLP-1 drug Bydureon (exenatide) – a long-acting form of its Byetta treatment.
Moncef Slaoui, chairman of R&D at GSK, said: “While the pre-specified margin of non-inferiority was not met, these topline data support continued progression towards registration of albiglutide as a possible future once weekly treatment for type II diabetes.
“This is the first of eight Phase III studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in type II diabetes,” he added.
GSK said initial results from the remaining seven Phase III studies would become available over the course of the next several months.
It added that an update on the clinical development programme is expected in mid-2012.
Ben Adams
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