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US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
Date:8/16/2009

er of breakthrough therapies which remain important treatments to this day," said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. "We are committed to providing new approaches to MS care, and the FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the US."

Extavia will be available to patients in the US this fall. Along with their prescription for Extavia, patients will be given access to a support program including a nurse helpline, one-on-one injection training and reimbursement support services. Extavia patients will have an autoinjector available to them from Novartis.

"MS is unpredictable and can be difficult to manage," said Aaron Miller, MD, Professor of Neurology at Mount Sinai School of Medicine in New York, USA. "Support programs are an essential element to help patients and physicians effectively manage this complicated disease."

MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (known as exacerbations or relapses), followed by complete or partial restoration of function(6).

Interferon beta-1b has been shown to reduce annualized relapse rates by 34% (p=0.0001)(8), with patients nearly twice as likely to remain relapse-free for more than two years compared to those receiving placebo (31% vs. 16%, p=0.007)(8). In addition, treatment with interferon beta-1b may slow disease progression(9). After two years, almost three-quarters of patients who experienced a single episode of neurological disease lasting 24 hours or more did not progress to clinically definite MS(10).

In the European Union Extavia is available in 12 countries and is approved for relapsing-remitting MS as well as early MS (defined as a single demyelinating event with an active inflammatory process) and a steadily worsening form of the disease known as secondary progressive MS with relapses
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SOURCE Novartis Pharmaceuticals Corporation
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