Biogen Idec Inc., a biotechnology company that specializes in multiple sclerosis treatments, won U.S. approval for a long-lasting hemophilia B drug that may reduce the need for infusions.
The medicine called Alprolix was cleared to treat the blood disorder, the Food and Drug Administration said today in a statement. The medicine replaces the factor IX protein that helps blood clot. Biogen and Swedish Orphan Biovitrum AB are partners on the development of Alprolix.
Current treatments can require several infusions a week, Tony Kingsley, executive vice president of Biogen’s global commercial operations, said in an interview. Alprolix may be infused once a week or less frequently depending on the patient, he said. Biogen’s drug would compete with Pfizer Inc.’s BeneFix, which generated $832 million in 2013, and Baxter Healthcare AG’s Rixubis approved last year.
Hemophilia is an inherited disorder that impairs blood coagulation and leads to bleeding. Males are at higher risk of developing hemophilia B. The condition is far less common than hemophilia A and affects about 4,000 people in the U.S., Kingsley said.
The FDA granted Alprolix orphan drug status, meaning the medicine treats a rare disease and Biogen is allowed an extra seven years to sell the drug without generic competition.
In a final-phase study on Alprolix patients who had weekly injections to prevent hemorrhage had 2.95 median bleeds in a year including spontaneous and traumatic bleeds. Those who used the drug on an individualized basis had 1.38 median bleeds.
Ninety percent of patients who had bleeding episodes controlled the bleeding with one shot of the drug.
Biogen hopes to bring its hemophilia A drug, to be called Eloctate, to market in the middle of this year, Kingsley said. Both of Biogen’s hemophilia treatments have seen delays in approval as the FDA sought more information on the manufacturing process. Biogen answered the agency in both cases, Kingsley said.