Novartis Gilenya Patient Develops Rare and Fatal Brain Disease

Novartis AG said on Friday that a patient who had been treated with its multiple-sclerosis (MS) drug Gilenya was recently diagnosed with a rare and usually fatal brain disease.

The Swiss drug manufacturer said that the patient (whose identity has not been disclosed) was previously treated with the MS drug Tysabri, which is co-marketed by Biogen Idec Inc. and Elan Corp. PLC, and has been linked already to progressive multifocal leukoencephalopathy, or PML. “The current assessment is that Tysabri is the drug most likely associated with this case of PML,” Novartis said. “However, a contribution of Gilenya to the evolution of this case can’t be excluded.”

The development of brain disease in the Gilenya patient comes at an unfortunate time for the Novartis drug. It’s safety has already been called into question following the death of one U.S. citizen last fall within 24 hours of taking the drug. Some patients report heart problems.

Novartis said that it doesn’t know (or can’t confirm) any PML cases in patients on Gilenya, but the company is cooperating, submitting details of the case to health authorities. Elan spokeswoman Niamh Lyons said: “”At this stage we can’t comment on the role that either drug might have had in this PML case.” Biogen wasn’t available for comment.

“The development has to be taken seriously, but the question is more whether this is a trend, with a second or even third case coming up in the next few weeks,” said analyst Andrew Weiss with Vontobel in Zurich. “The timing is unfortunate, with the pill’s risk-profile under investigation and certainly, there was no need for a second problem,” he continued.


Gilenya is the only MS treatment that can be taken orally currently on the market. So far it has been approved in over 55 countries, and over 25,000 patients have been prescribed it. Industry analysts have predicted sales of at least $1 billion in a year, which will help Novartis in light of their cancellation of the heart drug Diovan.