Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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.

Register
To receive FREE breaking news email alerts for Sanofi and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
European stocks are seen opening lower on Monday, tracking weak commodity prices and a subdued trend across the Asia-Pacific region as investors look ahead to Chinese manufacturing data due on Tuesday for important clues about China's growth outlook. China is experiencing stable growth and there... Specialty drugmaker Horizon Pharma plc (HZNP) on Friday managed to redomicile itself as an entity incorporated in Ireland following the completion of its $660 million acquisition of Vidara Therapeutics International plc. The deal will help it avoid paying the high rate of U.S. corporate taxes. The... Stocks showed a lack of direction over the course of the trading day on Friday after failing to sustain an initial upward move. Despite the choppy trading, the Dow once again managed to end the session at a new record closing high. The major averages turned in a mixed performance on the day.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.