Novartis: First MS Pill Approved
Updated with statement from Biogen Idec.
WASHINGTON, D.C. ( TheStreet) --U.S. regulators approved Novartis' (NVS - Get Report) Gilenya, the first treatment for multiple sclerosis that patients take as a once-daily pill, the company announced Wednesday.
Gilenya's approval by the U.S. Food and Drug Administration instantly changes the competitive landscape for multiple sclerosis (MS) drugs. Existing MS drugs made by Biogen Idec (BIIB - Get Report), Merck KGaA, Bayer and Teva Pharmaceuticals (TEVA - Get Report) are all administered by injection.
Novartis is now the only company to offer an oral MS drug, which may spark instant demand from doctors and patients eager for the convenience of a pill. Studies have also demonstrated that Gilenya works better than some of its competitors at tamping down the symptoms of MS. One of the pivotal studies used to approve Gilenya showed the drug to be superior to Biogen's Avonex in preventing MS relapses.Counteracting the excitement for the new MS pill, however, is a side effect profile that may make doctors hesitant to use Gilenya ahead of older, more established MS drugs. Investors were widely expecting FDA to approve Gilenya, although the agency did so without a restrictive black box warning for safety concerns and a patient monitoring system less onerous than expected. "Gilenya has been approved for multiple sclerosis in the U.S. with a prescribing label and a REMS
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