Genzyme has announced that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved Lemtrada (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
“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,” says Norma Deri, Hosptial Fernandez, Buenos Aires, Argentina. “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.”
Lemtrada is supported by a comprehensive and extensive clinical development programme that involved nearly 1,500 patients and 5,400 patient-years of follow-up. In addition to Argentina, Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil and Guatemala. Lemtrada is currently not approved in the United States. Genzyme recently announced that the US Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its application seeking approval of Lemtrada. Genzyme expects FDA action on the application in the fourth quarter.
Lemtrada 12mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
“We are pleased by the continued global support for Lemtrada,” said Genzyme President and CEO, David Meeker. “We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review.”