FDA Approves Eloctate for Patients with Hemophilia A

The U.S. Food and Drug Administration has approved Eloctate,  a first therapy designed to treat adults and children with Hemophilia A.

In an announcement the federal regulators approved Eloctate (Antihemophilic Factor (Recombinant), the first Hemophilia A treatment drug.

This treatment reduces the frequency of injections needed to control bleeding in hemophilia patients.

Eloctate not just regulates bleeding episodes but also manages bleeding during surgical procedures and prevents or reduces the frequency of bleeding episodes called prophylaxis.

Manufactured by Biogen Idec, Eloctate has a Coagulation Factor VII molecule that is associated to a protein fragment Fc, generally found in antibodies. This protein makes the product active for a longer duration in the patient's blood.

"The approval of this product provides an additional therapeutic option for use in the care of patients with Hemophilia A," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.

Hemophilia A is a sex-linked blood clotting inherited disorder that mostly affects males and is present due to the defect in the Factor VII gene.  This disorder is known to affect 1 in every 5,000 males in the U.S. People diagnosed with this disorder experience repeated episodes of serious bleeding especially in the joints.

A clinical trial was conducted on 164 patients to test the safety and efficacy of the therapy. Eloctate helped control bleeding during and after surgical procedures.

This therapy has received an orphan-drug designation as it is meant to treat a rare disease or condition.