Biogen Idec announced on March 28th that the FDA approves orphan drug Alprolix (coagulation factor IX (recombinant), Fc fusion protein), the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body for use in children and adults.
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.
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