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ARTICLE | Regulation

Fingolimod: Test, then use

FDA panel backs oral fingolimod for MS if patients take battery of tests up front

June 14, 2010 7:00 AM UTC

An FDA advisory committee has given the agency a strong recommendation to approve fingolimod from Novartis AG as the first oral treatment for MS - indeed, backing first-line use of the drug - even though the panel concluded patients should be tested to rule out potential safety problems prior to use.

Last week, FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 25-0 that fingolimod was effective at reducing the clinical exacerbations of MS and that the safety of the 0.5 mg dose justified approval...