FDA Approves Eloctate, Biogen Idec's Hemophilia A Drug

The FDA announced that it has approved Biogen Idec’s Hemophilia A drug, Eloctate, for the treatment of bleeding episodes. Eloctate is a combination drug that uses a combination of different proteins, including the Coagulation Factor VIII molecule. The Coagulation Factor VIII molecule is associated with the Fc protein fragment, which allows the drug to remain in the body longer.

Eloctate was designed to stop bleeding episodes as well as to reduce the frequency of bleeding problems. The drug will also be used to stop bleeding caused during surgical procedures.

In clinical trials, Eloctate performed well; 164 patients enrolled in the study saw improved preventative measures and bleeding episode management when treated with Eloctate. The drug is expected to generate as much as $1.5 billion in sales by 2019. Biogen Idec also has a treatment for hemophilia B called Alprolix, which was approved by the FDA in March. By 2019, Alprolix sales are forecasted to hit $285 million. Douglas Williams, the head of research and development for Biogen Idec, has said that both drugs are “the anchor tenants in a growing franchise.”

Hemophilia A is a bleeding disorder that is inherited and primarily in males. It is estimated that 1 of every 5,000 males in the U.S.  It is the most common of the hemophilia genetic disorders, and patients afflicted with the condition lack the clotting factor VIII protein. That protein allows the body to naturally stop bleeding episodes through coagulation. When the blood can’t coagulate, then bleeding can become excessive and cause serious problems.

Dr. Karen Midthun, the director of the FDA’s Center for Biologics Evaluation and Research, commented on the approval of the drug. “The approval of this product provides an additional therapeutic option for use in the care of patients with Hemophilia A,” she said.