INTRODUCTION Biogen Idec is the first biotechnology company to receive approval from the US Food and Drug Administration (FDA) for a recombinant coagulation factor long acting, intended for use in patients suffering from haemophilia B (Christmas disease). Approved under the proprietary name Alprolix, Coagulation Factor IX (Recombinant), the Fc fusion protein is therapeutically designed to remain in circulation for a long time and requires less recurring injections from users. Alprolix is ​​an innovation that is improving the treatments and quality of life of patients with deficient or dysfunctional congenital factor IX. SUBMISSION DETAILS Submission type BLA#BL STN 125444/0 Decision: Approved Decision date: 03/29/2014 Trade name and brand: Active ingredient: ALPROLIX™/Coagulation Factor IX (recombinant), Fc fusion proteinFusion protein recombinant comprising the human coagulation factor IX sequence linked to the Fc domain of human immunoglobulin G1 (IgG1)Sponsor name: Biogen Idec, Inc.Dosage form(s): Lyophilized powder with nominal potencies: 500 IU, 1000 IU, 2000 IU or 3000 IU per vial Approved therapeutic use: indicated in adults and children affected by haemophilia B for: • Control and prevention of bleeding episodes, • Perioperative management, • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.ALPROLIX ™ is not indicated for the induction of immune tolerance in patients with haemophilia B. Routes of administration: intravenous administration PDUFA rate: PDUFA VSPRODUCT BACKGROUNDAlprolix is ​​a sterile, lyophilised white powder for reconstitution with pre-filled pack provided diluent syringe, to be supplied as a solution for one route of administration by intravenous injection. It is produced......middle of paper......Products/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM391049.pdfU.S. Food and drug administration. (2014, April 16). Summary basis for regulatory action - ALPROLIX. Retrieved May 19, 2014, from ALPROLIX: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm393432.htmUS FDA. (2013, August 16). CLINICAL PHARMACOLOGY BLA REVIEW. (O. o. Research, Ed.) Retrieved May 19, 2014, from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM395349.pdfUS. FDA. (2014, March 28). FDA approves first long-acting recombinant coagulation factor IX concentrate for hemophilia B patients. Retrieved May 19, 2014, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391037. htm