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FDA Approves Oral Therapy
Gilenya (formally Fingolimod) has gained approval from the US Food and Drugs Administration, making it the first oral therapy approved for relapsing-remitting MS in the US. Gilenya is taken orally once a day and has shown to reduce relapse rate and delay the onset of disability.
A two year FREEDOM trial concluded in 2009 comparing Fingolimod with a placebo. The following results were published:
- Fingolimod reduced relaspse rates by 54 - 60% over the two year trial period
- Fingolimod reduced disability progression by 30% over three or six months as measured by the Expanded Disability Status Scale
- Fingolimod reduced brain lesion activity as measured by MRI scanning.
Read more about Gilenya (Fingolimod).
The European licence is currently being applied for with an indication expected in Spring 2011
Published by: MS Ireland on Friday September 24 2010
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