Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
Become a Member | Sign in
Home>News>This Article

FDA Accepts Biogen Idec’s Biologics License Application

Published: Tuesday, May 14, 2013
Last Updated: Tuesday, May 14, 2013
Bookmark and Share
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.

Biogen Idec announced 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.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,100+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

FDA Approves First Generic Versions of Antidepressant Drug Cymbalta
The U.S.FDA approved the first generic versions of Cymbalta), a prescription medicine used to treat depression and other conditions.
Monday, December 16, 2013
FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
Vaccine to supplement National Stockpile, not intended for commercial availability.
Wednesday, November 27, 2013
FDA Issues Draft Guidance on Biosimilar Product Development
The three draft guidance documents on biosimilar product development are to assist industry in developing such products in the United States.
Monday, February 13, 2012
Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
Overlooked Molecules Could Revolutionise our Understanding of the Immune System
Researchers have discovered that around one third of all the epitopes displayed for scanning by the immune system are a type known as ‘spliced’ epitopes.
Signaling Pathway Could Be Key to Improved Osteoporosis Treatment
Inhibition of SIK2 enzyme both stimulates bone formation and reduces bone breakdown in animal model.
Less Frequent Cervical Cancer Screening
HPV-vaccinated women may only need one screening every 5 to 10 years with screening starting later in life.
The Power Of Orthogonality In Assessing The Stability Of Biopharmaceuticals
By utilizing orthogonal techniques, researchers can maximize the secure application of all analytical results generated.
Dysfunction in Neuronal Transport Mechanism Linked to Alzheimer’s
Findings confirm mutation-caused problem but also reveal a new therapeutic target.
New Antibody Therapy Permanently Blocks SIV Infection
An international research team has developed an effective treatment strategy against the HIV-like Simian Immunodeficiency Virus (SIV) in rhesus macaques.
3D-Printing in Science: Conference Co-Staged with LABVOLUTION
LABVOLUTION 2017 will have an added highlight of a simultaneous conference, "3D-Printing in Science".
DNA Vaccines Protect Monkeys Against Zika Virus
Two experimental Zika virus DNA vaccines developed by NIH scientists protected monkeys against Zika infection.
Rare Flu-Thwarting Mutation Discovered
Study finds protein mutation, that is encoded by influenza, causes the virus to lose any defence against the immune system.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,100+ scientific videos