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

Genzyme’s LEMTRADA™ Application for MS Accepted for Review by the FDA

Published: Tuesday, January 29, 2013
Last Updated: Tuesday, January 29, 2013
Bookmark and Share
Genzyme also reports very encouraging early launch indicators for AUBAGIO® (teriflunomide) in U.S.

Genzyme, a Sanofi Company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the U.S. launch of once-daily, oral AUBAGIO (teriflunomide).

LEMTRADA sBLA Accepted by FDA

The FDA has accepted for standard review the company’s sBLA file seeking approval of LEMTRADA. Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2 2013.

The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis), randomized Phase III studies comparing LEMTRADA to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012.

AUBAGIO Early Launch Indicators in the U.S.

Since its launch in October, once-daily, oral AUBAGIO has shown very encouraging early launch indicators among U.S. prescribers.1 Key highlights from the launch include:

•    More than 80 percent of MS specialists in the U.S. have prescribed AUBAGIO;
•    Approximately 1 in 5 patients prescribed AUBAGIO were treatment-naïve;
•    More than 50 percent of AUBAGIO patients were most recently on Copaxone® or Avonex®

“Genzyme is making a difference for people living with MS and realizing its vision of being leaders in MS,” said Genzyme President and CEO, David Meeker, M.D. “The initial uptake of AUBAGIO by U.S. prescribers shows the importance of a once-daily oral option in MS. In addition, the acceptance of the LEMTRADA file in the U.S. marks another important milestone in bringing this potentially transformative therapy to MS patients. We look forward to a series of product launches in 2013 in Europe and other major markets.”

AUBAGIO is approved for use in both the U.S. and Australia.


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 5,000+ 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

Genzyme Celebrates Fifth Annual World MS Day
Company’s long-term commitment to MS extends beyond innovative therapies to new programs that address global needs of community.
Thursday, May 30, 2013
Scientific News
Bacteria Use Ranking Strategy to Fight Off Viruses
Researchers have explained why microbes store virus confrontation information sequentially, with most recent attacks first.
Molecular Switch Aids Immune Therapy
Researchers identify strategy to maximise effectiveness of immune therapy through molecular switch controlling immune suppression.
Reprogramming Lymph Nodes to Fight MS
Bioengineers work to reprogram lymph node function to fight multiple sclerosis.
Antibodies Block Norovirus’ Entrance into Cells
Scientists have uncovered a mechanism in the human body that targets and successfully blocks noroviruses.
Probe Detects Histone Modifications in Cells
Scientists have developed an antibody probe that can be used to monitor the dynamics of histone modification.
Gut Pathogens Thrive on Body's Tissue-Repair Mechanism
Researcher have discovered that harm caused by pathogens in the intestinal tract benefit from immune system response to damaged intestinal lining.
Eisai Establishes AiM Institute
The Andover innovative Medicines (AiM) Institute will develop innovative precision medicines for hard-to-treat conditions.
Antibodies that Target Holes in HIV's Defence Identified
Scientists suggest 'holes' in HIV sugar sheild can be targeted by antibodies.
Arms Race with a Superbug
Scientists have discovered that increased risk of superbug infection can be directly casued by immune system response to invading bacteria.
Discovery Could Yield Improved Flu Vaccines
Researchers have discovered a type of immune antibody that can evolve to combat a number of infuenza virus strains.
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
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!