The US Food and Drug Administration (FDA) recently accepted Biogen Idec’s (BIIB - Analyst Report) Biologics License Application (BLA) for its hemophilia A candidate, Eloctate (recombinant factor VIII Fc fusion protein).
Biogen had submitted the BLA in Mar 2013. The regulatory filing was based on results from the A-LONG study. FDA approval for Eloctate would represent a significant advancement in hemophilia A treatment in more than two decades. The FDA has granted standard review which means a response regarding the approval status of Eloctate should be out early next year.
We note that Biogen’s hemophilia B candidate, Alprolix, is also under FDA review. With the FDA granting standard review, a response from the agency regarding the approval status of Alprolix should be out in the fourth quarter of this year.
A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help Eloctate and Alprolix capture share from existing products in the hemophilia market. According to Biogen, Eloctate has the potential to reduce the number of intravenous injections by 50 to 100 per year in patients currently on preventive treatment.
We are pleased with the pipeline progress at Biogen. The company received a major boost in late March with the FDA approval of its oral multiple sclerosis drug, Tecfidera. We expect Tecfidera to gain EU approval shortly - the Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the approval of Tecfidera in Mar 2013.
Biogen currently carries a Zacks Rank #3 (Hold). At present, companies like Anika Therapeutics Inc. , Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report) and Alkermes (ALKS - Analyst Report) look well-positioned. While Anika is a Zacks Rank #1 (Strong Buy) stock, Alkermes and Alexion are Zacks Rank #2 (Buy) stocks.