Orphan Drugs: Biogen Idec Receives FDA Approval
Biogen Idec announces on March 28th that the FDA approves orphan drug Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein), for use in children and adults with Hemophilia B. It is the first long-acting recombinant coagulation Factor IX concentrate for Hemophilia B. Alprolix is made up of the Factor IX molecule linked to a protein fragment Fc (found in antibodies), which makes the product last longer in circulation. This results in less frequent injections for patients. According to Biogen Idec, “Alprolix is the first significant advance in Hemophilia B treatment in more than 17 years”.
Hemophilia B, which affects approximately 4,000 people in the United States and 28,000 worldwide, is an inherited sex-linked blood clotting disorder affecting mostly males. It is caused by defects in the Factor IX gene.
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of Alprolix. Biogen Idec has manufacturing and commercialization rights in North America and all other regions in the world excluding Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe, Russia, the Middle East and Northern Africa.
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