Gilenya has already been approved and is marketed in the US.
Today's approval was for second line use, meaning for patients who have already received, and have not responded to, other treatments for the disease.
The decision was not a major surprise to Teva or to Novartis. Earlier this year medical authorities in Europe said the drug was a good option for oral treatment, (as opposed to by injection, as Teva offers with its current version of Copaxone - O.R.)
Teva and Sanofi-Aventis are considered to see the greatest negative impact form the decision.
Analysts estimate that the multiple-sclerosis market will reach $15 billion by 2015.
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