Genzyme's Lemtrada For MS Gets Approval In Argentina
Sanofi company Genzyme announced that its relapsing remitting multiple sclerosis (RRMS) drug Lemtrada (alemtuzumab) has received approval from the Argentina’s National Administration of Drugs, Food, and Medical Technology (ANMAT).
The drug received approval in Argentina following the release of data from a clinical development program involving almost 1,500 patients. The drug has also received approval in the EU, Canada, and Brazil among other countries, though has yet to be approved in the US. It has been a long process for the company, which received a CRL for the drug last December. The company has since worked to prove the benefits of Lemtrada and has resubmitted its supplemental Biologics License Application to FDA for the drug.
Alemtuzumab is a monoclonal antibody that targets the protein CD52, found on T and B cells. The drug, through elimination of these circulating T and B cells, helps ease the inflammation characteristic of multiple sclerosis. Once inflammation has been controlled, T and B cell repopulation occurs that potentially reduces MS disease activity.
“The Lemtrada clinical trial data demonstrating the treatment’s positive impact on relapse rates and disability progression support its potential as a transformational new treatment for relapsing-remitting multiple sclerosis. The approval of Lemtrada is good news for people living with active MS, who are in need of additional treatment options that may offer greater efficacy,” said Norma Deri, Hospital Fernandez in Buenos Aires, Argentina. Over 2.3 million people around the world suffer from multiple sclerosis, with an estimated 8,000 in Argentina.
Genzyme holds global rights to alemtuzumab and leads its development and commercialization in multiple sclerosis. Bayer HealthCare has the rights to co-promote alemtuzumab in MS in the U.S.
President and CEO of Genzyme David Meeker said, “We are pleased by the continued global support for Lemtrada. We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review.”