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:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Penn and Teller give take on vaccines

The Las Vegas twosome give the anti-vaccination movement their signature treatment.

GSK allegations build in Jordan and Lebanon

GlaxoSmithKline says it is investigating allegations of employee misconduct. The company said in a statement that the allegations have numbers "very similar to those reported by other companies in our sector."

Generic Celebrex is coming

Pfizer and Teva's settlement puts generic Celebrex on the market by December.