Biogen’s new haemophilia drug gains US approval

Biogen’s Eloctate, the first ever long-acting treatment for haemophilia A, has been approved in the US.

Eloctate [Antihaemophilic Factor (Recombinant), Fc Fusion Protein] is the first treatment to reduce the frequency of bleeding episodes with prophylactic infusions every three to five days, allowing patients to extend the interval between prophylactic infusions.

The approval is part of the company’s growing portfolio of drugs for non-malignant blood disorders.

In March the FDA approved another Biogen drug, haemophilia B treatment, Alprolix. Biogen developed both drugs with Swedish Orphan Biovitrum (SOBI), and the companies expect them to become the foundation for a franchise in non-malignant blood disorders.

Analysts predict that sales of the two drugs can reach up to $1 billion by 2017, with revenues being shared 50/50 between Biogen and SOBI.

“The proven ability of Eloctate to provide protection from bleeding episodes with prolonged circulation marks the first significant haemophilia A treatment advance in more than 20 years,” said George Scangos, Ph.D., chief executive of Biogen Idec.

Baxter is the current market leader in haemophilia A, which is estimated to be worth $6 billion. It has its own longer-acting recombinant factor VIII protein, BAX 855, currently in late stage trials.

Other companies, such as Bayer and Novo Nordisk also have haemophilia drugs in the pipeline.

Haemophilia A is a rare, inherited blood clotting disorder that can lead to prolonged bleeding, bruising and joint and tissue damage. It is caused by having substantially reduced or no factor VIII activity, which is needed for normal blood clotting.

The World Federation of Hemophilia global survey conducted in 2012 estimates that approximately 142,000 people worldwide are identified as living with haemophilia A.

Biogen has a strong presence in malignant blood disorders – it has co-developed new anti-CD20 product, Gazyva (obinutuzumab) with Roche/Genentech. The drug is the first FDA-designated breakthrough therapy to gain approval.

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