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

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 4,000+ scientific posters on ePosters
  • More than 5,300+ 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 TechnologyNetworks.com 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
Improved Stability, Shelf Life of Protein Drugs
Study improves protein drug stability and extend their shelf life by tested a novel route for non-covalent protein modification.
More Effective Strategy for Producing Flu Vaccines
Researchers have developed a virus backbone, allowing producers to grow vaccine viruses in mammalian cells, rather than in eggs.
Improving Drug Production with Computer Model
A model has been developed that can be used to improve and accelerate the production of biotherapeutics, cancer drugs, and vaccines.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Vaccination Against UTIs
Researchers have successfully vaccinated mice against E.coli growth in the bladder and kidneys.
First Steps to Neutralising Zika
Researchers have discovered a highly potent antibody that neutralises Zika infection at a cellular level.
Fighting Off HIV Infection Closer to Reality
Researchers have made significant progress in the development of a potential vaccine to protect against HIV infection.
Human Astrovirus Structure Could Lead to Therapies, Vaccines
Study shows where neutralizing antibody binds to human astrovirus, a leading cause of viral diarrhoea in children, elderly, and the immune-compromised.
Dissecting Bacterial Infections at the Single-Cell Level
Researchers have used single-cell analysis technology to provide new insight into the Salmonella infection process.
Powerful New Tools to Combat Zika
Researchers have created a way to replicate the stucture of Zika virus, removing the genes that make the virus infectious.
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
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!