Biogen Idec and Sobi report positive haemophilia drug trial data

Biogen Idec and Sobi have announced positive data from a new study of long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc), their new haemophilia A therapy.

Results from the phase III trial A-Long showed that the drug was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management, as well as being generally well-tolerated.

It was found that 98 percent of bleeding episodes were controlled with one or two injections of rFVIIIFc, while no patients developed inhibitors to the therapy.

Biogen Idec will file for US regulatory approval of the drug in the first half of 2013, while a corresponding submission will be made to the European Medicines Agency following the completion of the ongoing Kids A-Long study.

Dr Glenn Pierce, senior vice-president of global medical affairs and chief medical officer of Biogen Idec's haemophilia therapeutic area, said: "These top-line results demonstrated that rFVIIIFc has the potential to enhance the care of people living with haemophilia A by offering protection from bleeding with reduced treatment burden."

This comes after Biogen Idec and Sobi last month reported similarly encouraging data from B-Long, a study assessing their recombinant Factor IX Fc fusion protein among haemophilia B patients.