FDA Accepts Biogen Idec's Biologics License Application for First Long-Lasting Factor VIII Therapy f
Mar 4th 2013 7:46AM
Updated May 13th 2013 10:05AM
FDA Accepts Biogen Idec's Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A
-ELOCTATE ™ Has Potential to Provide Long-Lasting Protection and Markedly Reduce Treatment Burden for Patients-
WESTON, Mass.--(BUSINESS WIRE)-- Biogen Idec (NAS: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for the marketing approval of ELOCTATE™ (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. ELOCTATE is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of providing long-lasting protection and reducing the burden of treatment for patients with this chronic condition.
"ELOCTATE has the potential to improve adherence by reducing the number of intravenous injections needed to prevent bleeds, which is an important need for people with hemophilia A," said Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec's hemophilia therapeutic area. "For those people currently on preventative—or prophylactic—treatment, ELOCTATE provides the potential to reduce the number of intravenous injections by 50 to 100 per year."
The ELOCTATE BLA was based on results from A-LONG, the largest registrational phase 3 clinical study in hemophilia A to date. In the A-LONG study, patients who injected ELOCTATE once-weekly to twice-weekly had low annualized bleeding rates. Prophylaxis in hemophilia A typically requires injections three times per week or every other day to maintain a sufficient circulating level of factor VIII, which prevents debilitating bleeding episodes.
With the FDA's acceptance of the ELOCTATE BLA, Biogen Idec now has product candidates for both hemophilia A and B under review with the agency. On March 4, 2013, the company announced that the FDA accepted for review the BLA for its factor IX candidate, ALPROLIX™ (recombinant factor IX Fc fusion protein), for the treatment of hemophilia B. Both applications were granted standard review.
About the Fc Fusion Technology Platform
ELOCTATE is a clotting factor developed using Biogen Idec's novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway to delay the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life.
With this technology, ELOCTATE is designed to provide long-lasting protection from bleeding and reduce the treatment burden associated with hemophilia A, which currently can require approximately 150 to 180 injections annually for prophylaxis with commercially available factor VIII products. Fc fusion technology is used in seven FDA-approved products for the long-term treatment of chronic diseases including rheumatoid arthritis, psoriasis and platelet disorders.
About Hemophilia A
Hemophilia A is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Hemophilia A occurs in about one in 5,000 male births annually and is caused by having substantially reduced or no factor VIII activity, which is needed for normal blood clotting. People with hemophilia A therefore need injections of factor VIII to restore the coagulation process and prevent frequent bleeds that could otherwise lead to pain, irreversible joint damage and life-threatening hemorrhages. The Medical and Scientific Advisory Council of the National Hemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe hemophilia A.
About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of ALPROLIX in hemophilia B and ELOCTATE in hemophilia A. Biogen Idec leads development, has manufacturing rights, and has commercialization rights in North America and all other regions excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe including Russia, the Middle East and Northern Africa.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
This press release contains forward-looking statements, including statements about the potential impact of our long-lasting hemophilia product candidates and regulatory filings. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Biogen Idec Media:
Todd Cooper, +1-781-464-3260
Senior Director, Public Affairs
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Senior Manager, Investor Relations
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