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.