The U.S. Food and Drug Administration said it was investigating a case of a rare and serious brain infection that developed in a patient in Europe, who was being treated with Novartis’s multiple sclerosis drug, Gilenya. The FDA said this was the first instance of the infection, called progressive multifocal leukoencephalopathy (PML), being reported in a Gilenya patient, who had not previously received Biogen Idec’s Tysabri. Tysabri is another multiple sclerosis (MS) drug associated with a high risk of PML. Demand for the drug has slowed due to concerns over the potentially fatal infection.
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