Biogen Idec: FDA Okays Eloctate To Treat Hemophilia A

(RTTNews) - Biogen Idec Inc (BIIB) said Friday the U.S. Food and Drug Administration approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A.

Hemophilia A is an inherited, sex-linked, blood clotting disorder, which primarily affects males, and is caused by defects in the Factor VIII gene.

The FDA approval means Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding, Biogen Idec said in a statement.

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.

Hemophilia A is said to affect 1 in every 5,000 males born in the U.S. People with Hemophilia A can experience repeated episodes of serious bleeding, mainly into the joints, which can be severely damaged by the bleeding.

The safety and efficacy of Eloctate were evaluated in a clinical trial of 164 patients that compared the prophylactic treatment regimen to on-demand therapy. The trial demonstrated that Eloctate was effective in the treatment of bleeding episodes, in preventing or reducing bleeding and in the control of bleeding during and after surgical procedures. No safety concerns were identified in the trial.

The FDA action follows approval of Biogen's hemophilia B therapy, Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], in the U.S., Canada and Australia.

Biogen Idec stock closed Friday at $317.55, down $2.58 or 0.81%, on a volume of 679k shares on the Nasdaq. In after hours, the stock gained $1.85 or 0.58%.