PHARMA/BIOTECH UPDATE: Biogen’s Long-lasting Hybrid Drug Submitted to FDA

Earlier this week Biogen Idec announced that the company had filed for a Biologics License Application with the U.S. Food and Drug Administration (FDA). They seek marketing approval of their recombinant factor IX Fc fusion protien (rFIXFc) for treatment of Hemophilia B.

rFIXFc combines clotting factor IX with an immunoglobulin (an antibody) molecule that slows the rate at which the body metabolizes the protein. What this means for Hemophilia B patients who infuse every other day or every third day is that they may be able to administer rFIXFc once a week (or better yet) once every two weeks.

“Fewer injections should improve compliance,” lead investigator Jerry Powell, who directs the Hemophilia and Thrombosis Center at UC Davis told Futurity. Great news, considering teenage hemophiliacs often drop off infusing increasing the risk for spontaneous bleeding.

“This is the first modification to coagulation factors to increase the half-life,” Powell says. “My hope is that other pharmaceutical companies will focus on developing additional long-lasting factors to treat other types of hemophilia.”

Photo Credit: Biogen Idec

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