Novartis reports first PML case in a Gilenya patient

Novartis AG (NYSE:NVS; SIX:NOVN) said one multiple sclerosis (MS) patient treated with Gilenya fingolimod for about 3.5 months was diagnosed with progressive multifocal leukoencephalopathy. The patient began receiving Gilenya about six weeks after finishing 3.5 years of treatment with Tysabri natalizumab, which carries a boxed warning about the risk of PML. Gilenya's label does not mention PML. The patient tested positive for anti-JCV antibodies. Novartis said Tysabri is the drug most likely associated with the case of PML, but added that Gilenya's contribution to the case cannot be excluded. The PML case is the first reported in about 36,000 patients treated with Gilenya, of whom about 2,400 were treated for more than two years and about 500 for more than four years. ...