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 3,000+ scientific posters on ePosters
  • More than 4,400+ 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
Gut Microbiomes Of Infants Have An Impact On Autoimmunity
Exposure to pathogens early in life is beneficial to the education and development of the human immune system.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
COPD Linked to Increased Bacterial Invasion
Persistent inflammation in COPD may result from a defect in the immune system that allows airway bacteria to invade deeper into the lung.
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
Vaccinations Are More Effective When Administered In The Morning
Research from the University of Birmingham shows that influenza vaccinations have more protective responses when administered in the morning.
Secrets of a Deadly Virus Family Revealed
Scripps Research scientists uncover the glycoprotein structure of LCMV. The findings could guide development of treatments for Lassa fever.
Cytokine Triggers Immune Response at Expense of Blood Renewal
Research highlights promise of Anti-IL-1 drugs to treat chronic inflammatory disease.
Reduced Immune Response Causes Flu Deaths in Older Adults
Yale study suggests that immune response to flu causes death in older people, not the virus.
Exposure To Routine Viruses Makes Mice Better Test Subjects
Study shows that infections make mouse immune system act more like that in humans.
Immune Booster Tested in Advanced Merkel Cell Cancer
The immunotherapy drug produced durable responses in many patients.
SELECTBIO

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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!