Genzyme's MS drug approved in Brazil
Three months after being denied approval by the U.S. Food and Drug Administration, Cambridge-based Genzyme has won approval of its multiple sclerosis treatment in Brazil.
The treatment Lemtrada, is intended to slow or reverse physical disability and reduce frequency of flare-ups in MS patients.
“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 Dr. Maria Lucia Brito Ferreira, head of neurology at Hospital da Restauração, in 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.”
According to Genzyme, which has facilities in Northborough and Framingham, more than 2.3 million people worldwide have MS, including 30,000 in Brazil.
Lemtrada’s trial in Brazil involved nearly 1,500 patients. The drug is given in 12 mg doses with two treatments per year. The first is given through an IV for five consecutive days and the second for three days 12 months later.
It is already approved in Mexico, Canada, Australia and the European Union, and the company is seeking approval in other countries. In December, the FDA rejected Lemtrada over concerns about its trial design and potentially serious side effects that include increased risk of autoimmune and thyroid diseases such as diabetes and cancer. Genzyme plans to appeal the decision.
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