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FDA starts review of Biogen Idec's haemophilia A therapy

Could gain US approval by the first quarter of 2014

Biogen Idec building

The US FDA has started the review process for Biogen Idec's long-acting haemophilia drug Eloctate, setting up a possible approval in the first quarter of 2014.

The company filed for approval of Eloctate - a recombinant factor VIII Fc fusion protein (rFVIIIFc) - in March as a treatment for haemophilia A, the most common form of the bleeding disorder.

Eloctate was developed in partnership with Swedish Orphan Biovitrum (Sobi), which also collaborated on the development of Biogen Idec's haemophilia B candidate Alprolix (recombinant factor IX Fc fusion protein; rFIXFc). The pharma company filed for approval of Alprolix in the US in January.

Both new therapies are designed to reduce the number of injections needed for haemophilia patients, according to Biogen Idec, which noted that those on preventative Factor VIII regimens could see the number of shots reduced by 50 to around 100 a year.

Eloctate was submitted on the back of the results of the A-LONG trial, which found that once-weekly or twice-weekly injections of the drug was associated with low annualised bleeding rates.

The greater convenience for haemophilia A and B patients - who typically have to receive three or four injections a week with current therapies - could help Biogen Idec mount an assault on a haemophilia market currently led by Baxter International with its haemophilia A treatment Advate and Pfizer's haemophilia B  drug BeneFIX.

Meanwhile, Biogen Idec has a clearer run at the haemophilia market following Bayer's decision earlier this month to halt development of its BAY 86-6150 candidate - which had reached phase II/III testing - after it was found to stimulate a neutralising antibody response in patients.

Also in the frame is Novo Nordisk, which has long-acting candidates for haemophilia A (NN7088) and haemophilia B (NN7999) in phase III testing and is running around a year behind Biogen Idec, while Baxter and CSL Behring also have long-acting products in trials.

14th May 2013

From: Sales



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