Genzyme's MS Drug Lemtrada Wins Approval In Brazil

Sanofi company Genzyme announced that it has received approval from Brazil’s national health surveillance agency ANVISA for its drug Lemtrada (alemtuzumab) for the treatment of multiple sclerosis (MS).

Maria Lucia Brito Ferreira, M.D., Head of Neurology at the Hospital da Restauração in Recife PE, Brazil, said, “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. Lemtrada will provide physicians with a promising new option for their patients with active MS and could change the way this disease is managed.”

Alemtuzumab is a monoclonal antibody designed to selectively target CD52, a protein found in abundant numbers on T and B cells. Using the drug leads to the depletion of circulating T and B cells considered to be responsible for the harmful inflammatory process in MS. A distinctive pattern of T and B cell repopulation follows treatment with alemtuzumab, which the company says rebalances the immune system to reduce MS disease activity.

Over 2.3 million people around the world have been diagnosed with MS, including an estimated 30,000 patients in Brazil.

The drug was approved for treatment of patients with elapsing forms of MS to help slow down or reverse the accumulation of physical disability and frequency of clinical exacerbations. The approval for Lemtrada was based on an extensive clinical development program involving almost 1,500 patients. “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,” Genzyme said in its press release.

The FDA issued a complete response letter to Lemtrada last December. The company said it intends to appeal the decision. Marketing authorization applications for the drug are currently under review in other countries.