FDA Approves Biogen Idec's Hemophilia B Drug Alprolix

(RTTNews) - Biogen Idec Inc. (BIIB) said Friday that the U.S. Food and Drug Administration has approved Alprolix, the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.

Alprolix is indicated for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic infusions starting at least a week apart.

Hemophilia B is a rare, chronic, inherited disorder in which the ability of a person's blood to clot is impaired, which can lead to recurrent and extended bleeding episodes.

The approval of Alprolix is the first significant advance in hemophilia B treatment in more than 17 years. The therapy is clinically proven to reduce bleeding episodes with a favorable safety and tolerability profile. It is developed using a process called Fc fusion and is the first hemophilia therapy to demonstrate prolonged circulation in the body, which has been shown in adults and adolescents with hemophilia to extend the time between prophylactic infusions.

Biogen Idec plans to make Alprolix commercially available in the United States in early May.

The approval of ALPROLIX is based on results from the global, Phase 3 B-LONG study, as well as interim pharmacokinetic and safety data from the Phase 3 Kids B-LONG study. B-LONG study results showed that adults and adolescents with severe hemophilia B achieved prevention or reduction of bleeding episodes with prophylactic infusions at least a week apart. The study included two prophylaxis regimens - the weekly prophylaxis arm and the individualized-interval prophylaxis arm, in which the dosing interval started at once every 10 days. The overall median dosing interval with individualized-interval prophylaxis was 12.5 days; during the last six months of the study, the median interval was 13.8 days. More than 90% of all bleeding episodes were controlled by a single ALPROLIX infusion.

ALPROLIX was recently approved by Health Canada for the treatment of hemophilia B and is currently under review by regulatory authorities in several other countries, including Australia and Japan.