Lemtrada is supported by a clinical development program that involved about 1,500 patients and 5,400 patient-years of follow-up.
The approval in Brazil follows the recent approvals of Lemtrada in Mexico, Canada, Australia and the European Union (EU).
The company said that lemtrada is currently not approved in the US.
In December 2013, the company secured a complete response letter from the US FDA on its application for US approval of Lemtrada and announced its intent to appeal this decision. Marketing applications for Lemtrada are also under review in other countries.
Brazil’s Hospital da Restauração head of Neurology Maria Lucia Brito Ferreira said lemtrada is an new treatment, with clinical trial data that support its potential to meaningfully address relapse rates and disability in patients with active MS.
"Lemtrada will provide physicians with a promising new option for their patients with active MS and could change the way this disease is managed," Ferreira said.
The company said that Lemtrada 12mg has a new dosing and administration schedule of two annual treatment courses.
The first treatment course of Lemtrada is administered through intravenous infusion on five consecutive days, and the second course is given on three consecutive days, 12 months later.
Most common side effects of Lemtrada are infusion associated reactions, infections, lymphopenia and leukopenia.