Biogen, Sobi share phase 3 results of haemophilia A drug

Biogen and the rare disease pharma company, Swedish Orphan Biovitrum AB (publ) (Sobi), have announced that the results of a phase 3 clinical trial support the clinical and safety profile of their haemophilia A drug, Eloctate.

The results show that Eloctate (recombinant factor VIII Fc fusion protein) has the potential to reduce the number of intravenous injections people with haemophilia A require, its efficacy in controlling bleeding during and after surgery, and its efficacy in treating acute bleeding episodes.

An evaluation of the treatment of acute bleeding episodes across the prophylaxis and episodic (on demand) treatment arms of the phase 3 A-LONG study showed that more than 87% of bleeds were controlled with a single injection of ELOCTATE and more than 97% of were controlled with two or fewer injections.

"We are excited to share these new data, which include patients' and physicians' assessment of ELOCTATE's efficacy in treating bleeding episodes and in controlling bleeding during surgery. The A-LONG data presented at ISTH support the potential of ELOCTATE to enable longer intervals between prophylactic (preventative) injections compared to the current standard of care."

Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec's hemophilia therapeutic area.

Haemophilia A is a rare genetic disorder in which the ability of a person's blood to clot is impaired. It occurs in about one in 5000 male births annually.