Argentina Regulatory Body Approves Genzyme's MS Drug

The National Administration of Drugs, Food, and Medical Technology (ANMAT) in Argentina has announced that it has approved Genzyme's Lemtrada for treating adult patients with the relapsing remitting form of multiple sclerosis. Genzyme had been looking to expand the market for the company’s MS drug, and Argentina, which is home to 8,000 people affected by MS, is an important market for Lemtrada.

David Meeker, the President and CEO of Genzyme, released a statement on the approval of Lemtrada in Argentina. “We are pleased by the continued global support for Lemtrada,” he said. “We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review.”

Lemtrada has already been approved in a number of countries outside the US, including Australia, Brazil, Canada, the European Union, Guatemala and Mexico. The drug was also approved for reimbursement in the United Kingdom. Lemtrada has yet to be approved for use in the US by the FDA.

The FDA previously noted that it had concerns about the safety and design of a Lemtrada clinical trial. The FDA also expressed concerns that the benefits Lemtrada did not outweigh the risks of treatment. Genzyme appealed the agency’s decision and stated in April that it was working with the FDA in order to submit its supplemental Biologics License Application. Genzyme has stated that, since the FDA has since accepted the resubmitted application, the company  expects to get a new decision on the FDA approval by the end of 2014.

Bayer HealthCare has the right to co-market Lamtrada for MS in the US.