As their European counterparts did last month, the FDA has recommended continued use of the Gilenya multiple sclerosis pill sold by Novartis, but did say the drug should carry stronger warnings about heart risks and that some patients should undergo increased monitoring. The move was largely expected after the European Medicines Agency issued a similar alert, despite arguments by a non-profit safety watchdog that further restrictions are needed.
Although cardiovascular risks were known at the time of approval two years ago, the regulatory review was undertaken in response to patient deaths, including an unexplained sudden death of one person within 24 hours after taking Gilenya for the first time (back story). The back-to-back regulatory decisions will likely ease investor concerns over the prospects for the pill, which Novartis continues to hope will generate blockbuster sales.
The drugmaker has been counting on Gilenya to help compensate for the loss of patent protection on such big-selling drugs as the Diovan blood pressure pill. Meanwhile, competition in the MS market looms as Biogen Idec plans to seek FDA approval for an oral pill shortly.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309