Novartis Gilenya Patient Has Infection After Taking Tysabri, from Bloomberg

A patient taking Novartis AG (NOVN)’s Gilenya multiple sclerosis pill contracted a potentially deadlybrain infection, adding to safety concerns about the Swiss drugmaker’s most promising potential blockbuster.

The patient used Tysabri, an injection from Biogen Idec Inc. (BIIB) and Elan Corp. (ELN), before using Gilenya, Novartis said in an e-mailed statement today. Tysabri increases the risk of the viral infection, known as progressive multifocal leukoencephalopathy, that usually leads to death or severe disability, according to a warning the drug’s label has carried since 2006.

“The current assessment is that Tysabri is the drug most likely associated with this case of PML,” Novartis said in the statement. “However, a contribution of Gilenya to the evolution of this case cannot be excluded.”

“At this stage, we cannot comment on any role Gilenya might have had in this PML case,” an Elan spokeswoman said in an e-mail from Dublin. A Biogen spokeswoman didn’t immediately return a call seeking comment.

The case is the first of the infection among the 36,000 people treated with Gilenya since it was first approved in 2010, which is reassuring because regulators are looking into unexplained deaths among Gilenya patients, according to analysts at Barclays Capital. (JNK) The U.S. Food and Drug Administration and the European Medicines Agency are investigating 11 deaths of Gilenya patients.

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