With FDA decision looming, GlaxoSmithKline nails EU OK for diabetes drug albiglutide

With its PDUFA date for the once-weekly diabetes drug albiglutide looming at the FDA next month, GlaxoSmithKline ($GSK) announced today that the European Commission has OK'd the GLP-1 drug for marketing.

The drug, which will be sold as Eperzan, has had mixed results in the clinic, failing to beat out Victoza at one stage in a head-to-head study. It also faces a crowded field of GLP-1 contenders, which help spur the production of insulin. But the approval marks another significant step forward for Glaxo, which scored 5 new drug approvals last year and was banking on albiglutide to help improve its success rate in clinical-stage drug development.

Glaxo rolled out a battery of 8 Phase III studies for the incretin hormone, which normalizes blood glucose levels in patients with Type 2 diabetes. Peak sales for this therapy were projected at $800 million by Deutsche Bank analysts, though many of these forecasts turn out to be wildly inaccurate.

Glaxo's biggest competition in the GLP-1 market, though, may ultimately not be Victoza or AstraZeneca's ($AZN) Bydureon, which is being revamped with an easier-to-use pen device after failing to measure up to early expectations. Instead, Eli Lilly's ($LLY) dulaglutide, which is under FDA review after proving non-inferiority to the once-daily Victoza, could pose the greatest threat to GSK's plans to carve out a hefty piece of the market share.

Mark Schoenebaum, an analyst at ISI Group, says the drug class is currently worth about $3 billion, with Victoza taking the lion's share. These new drugs, he adds, could help drive the market into the $4 billion to $5 billion range.

GlaxoSmithKline success in the clinic, which follows an R&D reorganization several years ago, hasn't been without setbacks. Several of its most innovative therapies, including darapladib and MAGE-A3, have flunked key Phase III tests in recent months. And GSK punted its interest in the Duchenne muscular dystrophy drug drisapersen after a Phase III failure. Just this morning, GSK also announced that it is pulling its EU application for a combo cancer therapy using Mekinist after determining that regulators wanted to see more data.

Vlad Hogenhuis, vice president and head, GSK global cardiovascular, metabolic and neurosciences franchise

Today, though, GSK has a new marketing program to launch in the coming months.

"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," says Vlad Hogenhuis, GSK's chief of the metabolic franchise. "The authorization 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."

The FDA's PDUFA date on albiglutide is April 15.

- here's the press release