Biogen Idec (BIIB) recently announced that its Biologics License Application (:BLA) for its long-acting factor IX (rFIXFc) candidate for hemophilia B has been accepted by the US Food and Drug Administration (:FDA) for standard review.
Biogen and its partner, Swedish Orphan Biovitrum, had presented positive phase III top-line results on rFIXFc last year. Results from the global, open-label, multi-center B-LONG study showed that rFIXFc was effective in controlling and preventing bleeding, routine prophylaxis, and perioperative management. Results showed that a single injection of rFIXFc helped control 90.4% of bleeding episodes.
A pharmacokinetic (:PK) analysis was also conducted. The approximate terminal half-life of rFIXFc was found to be 82 hours compared to 34 hours for Pfizer’s (PFE) BeneFIX.
The candidate was also found to be well-tolerated with no inhibitors to rFIXFc being detected or cases of anaphylaxis (severe allergic reaction) being reported. Patients in the study had all switched from marketed factor IX products.
Meanwhile, Biogen intends to file for FDA approval of its hemophilia A candidate, rFVIIIFc, in the first half of 2013.
A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help rFIXFc and rFVIIIFc capture share from existing products in the hemophilia market.
With the FDA granting standard review, a response from the agency regarding the approval status of rFIXFc should be out in the fourth quarter of this year.
Meanwhile, Biogen has some other significant pipeline catalysts coming up, the most important being an update on the regulatory status of Tecfidera (BG-12). Tecfidera, Biogen’s oral multiple sclerosis candidate, is currently under review in both the US and the EU. A response in the US should be out this month. We believe Tecfidera could become a leader in the oral multiple sclerosis market once launched.
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