FDA pushes review date for Biogen blood drug

Share this article:

FDA extended the review time for Biogen Idec's Alprolix, a candidate for hemophilia B, by three months, the company said today. The biotech added that it submitted “additional information related to the validation of a manufacturing step for Alprolix,” and due to the timing of that submission, the agency extended its PDUFA date to allow more time to review. Hemophilia B is a rare, inherited disorder that impairs the blood's ability to clot. Alprolix is also under review in Canada, Australia and Japan. Biogen Idec also has a long-acting recombinant coagulation factor pending approval for the treatment of hemophilia A. That drug, to be sold under the name Eloctate, was also delayed 90 days; its PDUFA date is coming up in 1Q14. Both products have orphan-drug status in the US.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

This compelling e-book shares a wealth of insights designed to help members of sales forces connect with elusive HCPs. An expanded version has also been created that includes video interviews and other multimedia content. Click here for access.