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Genzyme Gains Approval From Brazil For Monoclonal Antibody Lemtrada

Genzyme Corp., a biotechnology company and an unit of Sanofi (SNY: Quote), Friday said ANVISA, Brazil's national health surveillance agency, has approved Lemtrada for the treatment of patients with relapsing forms of multiple sclerosis to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

While Mexico, Canada, Australia and EU have approved Lemtrada, FDA has rejected the compound, a decision Genzyme intends to appeal in the future.

The development of the compound included two randomized Phase 3 studies, as well as an ongoing study. The first study, CARE-MS I, compared treatment using Lemtrada with high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease or were new to treatment. The second study, CARE-MS II, involved patients who had relapsed while on prior therapy.

In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, said the company. The company also said that 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 versus interferon beta-1a.

The side-effects of Lemtrada include infusion-associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Autoimmune conditions and serious infections can occur in patients receiving Lemtrada.

The first course of Lemtrada is administered through IV on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

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by RTT Staff Writer

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