Novartis reports PML case in Gilenya patient

Novartis AG (NYSE:NVS; SIX:NOVN) said a multiple sclerosis (MS) patient in Italy was diagnosed with progressive multifocal leukoencephalopathy (PML) after receiving Gilenya fingolimod for seven months. The patient had received interferon beta for one month in combination with azathioprine prior to receiving Gilenya, as well as repeated courses of high-dose corticosteroids over the course of the disease. Novartis said it will work with the reporting physician to further understand all possible contributing factors. According to the pharma, there have been no cases of PML attributed to Gilenya in about 71,000 patients treated to date.

Last year, Novartis reported that an MS patient who tested positive for anti-JCV antibodies and who had previously been treated with Tysabri natalizumab from Biogen Idec Inc. (NASDAQ:BIIB) prior to initiating treatment with Gilenya was diagnosed with PML. The pharma also confirmed on Tuesday that the previously reported PML case was not attributed to Gilenya (see BioCentury Extra, April 13, 2012). ...