Biogen Idec’s Eloctate gains FDA approval

The US Food and Drug Administration on Friday approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Eloctate, antihemophilic factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. The company’s shares edged 1% higher in after hours trading to $320.70.

This is the first regulatory approval worldwide for Eloctate and the therapy is currently under review by regulatory authorities in several other countries including Canada, Australia and Japan. It is being developed in cooperation with Swedish Orphan Biovitrum (STO: SOBI). Plans to file with the European Medicines Agency are in progress.

Eloctate is the first hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. Eloctate received orphan-drug designation for this use by the FDA because it is intended for treatment of a rare disease or condition.

Eloctate is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis). Eloctate consists of the Coagulation Factor VIII molecule (historically known as antihemophilic Factor) linked to a protein fragment, Fc, which is found in antibodies. This makes the product last longer in the patient’s blood.

There was a setback in the approval process last year, when  the company received a request from the FDA for additional information relating to their Eloctate marketing application.