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FDA approves Biogen Idec’s haemophilia drug

Eloctate now available to help control and prevent bleeding episodes
FDA headquarters White Oak

US regulators last week announced that Biogen Idec can market its drug Eloctate to control and prevent bleeding episodes in patients with haemophilia A.

The FDA decision comes just over two months after Biogen Idec won backing for another haemophilia drug with the US approval of Alprolix to treat haemophilia B.

Both drugs were developed in partnership with Swedish Orphan Biovitrum (Sobi), a biopharma that specialises in rare diseases. The A and B variants of haemophilia are classed as rare diseases in the US allowing Eloctate and Alprolix to be assessed as orphan products, giving certain incentives to Biogen Idec.

The approvals considerably strengthen Biogen Idec's interest in haemophilia - a disease that hinders the body's ability to clot blood, leading to episodes of serious bleeding.

Eloctate in particular is set to impress, with potential sales of $1.5bn per year according to a Reuters poll of analysts in the area.

These expectations are mainly built on the advancement in dosing that Eloctate offers compared to current therapies.

The drug is formed of the coagulation factor VIII molecule, which targets the defective gene in haemophilia A patients, and a protein fragment, Fc, which is found in antibodies

This Fc protein fragment is designed to prolong the therapy's circulation in the body using a natural pathway, meaning the drug stays in the body longer. The main consequence of this is that doctors can extend the interval between drug infusions, meaning patients face less frequent dosing.

“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 Dr George Scangos, CEO of Biogen Idec.

Other long-acting treatments in the works include Novo Nordisk's NN7088 and Bayer's BAY94-9027. Baxter and CSL Behring also have long-acting products in trials.

Article by
Thomas Meek

9th June 2014

From: Sales



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