Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that Brazil’s national health surveillance agency, ANVISA, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.
“Lemtrada is an innovative treatment, with clinical trial data that support its potential to meaningfully address relapse rates and disability in patients with active MS,”
said Maria Lucia Brito Ferreira, M.D., Head of Neurology, Hospital da Restauração, Recife PE, Brazil.
“Lemtrada will provide physicians with a promising new option for their patients with active MS and could change the way this disease is managed.”
Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 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. Lemtrada is currently not approved in the United States. In December, Genzyme received a complete response letter from the FDA on its application for U.S. approval of Lemtrada and announced its intent to appeal this decision. Marketing applications for Lemtrada are also under review in other countries.
More than 2.3 million people worldwide have been diagnosed with MS, including approximately 30,000 people in Brazil.
Lemtrada 12 mg 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.
The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif
) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Autoimmune conditions and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.