GlaxoSmithKline clears an EU hurdle with its once-delayed GLP-1 diabetes drug
The European Medicines Agency's Committee for Medicinal Products for Human Use voted in favor of albiglutide, GSK said, recommending approval for its once-weekly GLP-1 agonist that helps spur the body's natural insulin production. The EMA is not beholden to follow CHMP votes, but it generally does, and GSK expects to hear a decision this quarter.
Meanwhile, the drug is waiting around on final word from the FDA after the agency put off its decision until April 15, a relatively minor setback for GSK but one that allowed a growing stable of competitors to get a leg up in the crowded GLP-1 field.
Leading the market are once-a-day treatments from Novo Nordisk ($NVO) and AstraZeneca ($AZN), but analysts have high hopes for Eli Lilly's ($LLY) late-stage dulaglutide, which could be the first weekly GLP-1 drug to hit the U.S. market thanks to GSK's delay and Sanofi's ($SNY) move to put off a resubmission of its similar lixisenatide until 2015.
Meanwhile, Boehringer Ingelheim may well be chasing a share of the same market, as the German drugmaker recently rebooted its collaboration with Zealand Pharma by handing back a daily GLP-1 treatment in order to pick another candidate from a crop of compounds that includes some weekly formulations.
As for GSK, if and when albiglutide finally makes its way to the market, the drug may face the longest odds of leading the crowded space after failing to beat out Novo's Victoza in a head-to-head study.
- read GSK's release
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