Alprolix: Innovation in Treatment for Patients with Deficient or Dysfunctional Factor IX

1533 Words4 Pages

INTRODUCTION Biogen Idec is the first biotechnology company to receive approval from the US Food and Drug Administration (FDA) for a long-acting recombinant coagulation factor IX product, that’s intended for use in patients with Hemophilia B (Christmas Disease). Approved under the proprietary name Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein is therapeutically designed to be prolonged in circulation and requires less recurrent injections by users. Alprolix is an innovation that is advancing treatments and the quality of life for patients with deficient or dysfunctional congenital Factor IX. SUBMISSION DETAILS Type of Submission BLA#BL STN 125444/0 Decision: Approved Date of Decision: 03/29/2014 Trade and Brand name: Active Ingredient: ALPROLIX™/Coagulation Factor IX (Recombinant), Fc Fusion Protein Recombinant fusion protein comprising the human Coagulation Factor IX sequence linked to the Fc domain of human immunoglobulin G1 (IgG1) Sponsor’s 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 with Hemophilia 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 induction of immune tolerance in patients with Hemophilia B. Route(s) of administration: Intravenous Administration PDUFA Fee: PDUFA V PRODUCT BACKGROUND Alprolix is a sterile, lyophilized white powder for reconstitution with provided pre-filled diluents syringe, to render as a solution for an intravenous injection route of administration. It is manufactur... ... middle of paper ... ...Products/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM391049.pdf U.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.htm US 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.pdf US. FDA. (2014, March 28). FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B. Retrieved May 19, 2014, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391037.htm

More about Alprolix: Innovation in Treatment for Patients with Deficient or Dysfunctional Factor IX

Open Document