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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.”
clinical development program that involved nearly 1,500 patients and 5,400
patient-years of follow-up.
Australia and the European Union.
the United States.
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.
