Novel treatment for relapsing-remitting multiple sclerosis approved in the European Union, Australia, Canada and now Mexico
News Feb 05, 2014
Genzyme, a Sanofi company, announced on February 4 that Mexico’s national regulatory authority, COFEPRIS, has approved Lemtrada® (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (RRMS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.
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. Approval in Mexico follows the recent approvals of Lemtrada in Canada, Australia and the European Union. Lemtrada is currently not approved in the United States. In December 2013, Genzyme received a complete response letter from the FDA on its application for U.S. approval of Lemtrada. Genzyme plans to appeal the agency’s 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 15,000 people in Mexico. Lemtrada has been granted orphan drug designation in Mexico.
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 approvals in the European Union, Australia, Canada and now Mexico underscore Lemtrada’s potential to have a positive impact on the lives of MS patients,” said Genzyme President and CEO, David Meeker. “Genzyme remains committed to providing new hope for the MS community and plans this year to launch Lemtrada in more than 30 countries, and hopefully additional markets where the treatment is still under review.”
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 (The Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis - 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.
About Lemtrada® (alemtuzumab)
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.