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Tuesday, February 4, 2014

Genzyme’s Lemtrada® Approved in Mexico for Treatment of Multiple Sclerosis

See petition information found below this article:

Cambridge, Mass. – February 4, 2014 – Genzyme, a Sanofi company announced today that Mexico’s national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

The approval of Lemtrada in Mexico is an important step forward for MS patients, who remain in great need of new treatment options that may offer greater efficacy,” said Miguel A. Macias, M.D., Department of Neuroscience, University of Guadalajara.  “The positive effect on disability progression demonstrated in clinical studies underscores Lemtrada’s ability to address the course of disease in a potentially transformative way for patients with relapsing remitting MS.

Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up.  

Approval in Mexico follows the recent approvals of Lemtrada in Canada, Australia and the European Union. 

Lemtrada is currently not approved in the United States. 

In December, Genzyme received a complete response letter from the FDA on its application for U.S. approval of Lemtrada.  Genzyme plans to appeal the agency’s decision.  Marketing applications for Lemtrada are also under review in other countries.




CLICK the above link to review petition labeled:

Thousands of Multiple Sclerosis patients are getting worse each day; They need another Option, another choice


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