FDA issues safety alert over MS drug Gilenya


A patient who was taking the multiple sclerosis drug Gilenya, manufactured by Novartis, developed a rare brain infection, according to safety alert by the FDA.

The alert stated that this is the first case of progressive multifocal leukoencephalopathy (PML), in a patient taking Gilenya who had not already received the MS drug Tysabri. Tysabri (manufactured by Biogen Idec) is, according to the agency, associated with a higher risk of PML.

"We are working with Gilenya's manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete."

The FDA safety alert

In a statement from Novartis, it was stated that having reviewed all available information, the company considered that several features of this case of PML made it unlikely to be attributable to Gilenya.



Reference link:

FDA Drug Safety Communication: FDA investigating rare brain infection in patient taking Gilenya (fingolimod) (FDA saftey alert)

Related news:

FDA Warns of PML Case With Gilenya (MedPageToday)

Novartis' MS drug Gilenya tied to rare brain infection (FiercePharma)


30 August, 2013