Half-life of rFVIIIFc may enable prophylactic dosing once to twice weekly
“This regulatory submission marks another significant step toward our
goal of transforming the care of hemophilia for patients, families and
Typically, prophylaxis in hemophilia A requires injections three times per week or every other day to maintain a sufficient circulating level of clotting factor to provide protection from bleeding. Without prophylactic treatment, people with hemophilia A remain at risk of bleeding episodes that can cause irreversible joint damage and life threatening hemorrhages.
About the Fc Fusion Technology Platform
Recombinant FVIIIFc is a clotting factor developed using Biogen Idec’s novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway that delays the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life.
With this technology, rFVIIIFc 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
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
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 dosage, commercialization and impact of
long-lasting hemophilia therapies 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
Biogen Idec Media Contact:
Amanda Galgay, +1-781-464-3260
Biogen Idec Investor Relations Contact:
Kia Khaleghpour, +1-781-464-2442
Director, Investor Relations