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Second Case of PML Reported in Person Receiving Gilenya®

March 10, 2015

UPDATED March 13, 2015

Novartis has confirmed that it has received a report of a second case of PML (progressive multifocal leukoencephalopathy, a viral infection of the brain that often leads to death or severe disability) that occurred in a person taking Gilenya® (fingolimod, Novartis AG). According to the company’s statement on February 2015, this individual, the first with a confirmed diagnosis of MS, received more than four years of Gilenya treatment before being diagnosed with PML, and is currently doing well. The company has reported the case to the U.S. Food and Drug Administration (FDA) and other health authorities. 

The FDA had previously announced on August 2013 that it was investigating an initial case of PML in a person taking Gilenya. According to a statement by Novartis, this individual's underlying disease was an aggressive form of Neuromyelitis Optica spectrum disorder (NMO) and not multiple sclerosis.  

PML is caused by the activation of a virus called the JC (John Cunningham) virus, and it has emerged in people using other medications, including the MS treatment Tysabri (natalizumab, Biogen Idec), and the MS treatment Tecfidera (dimethyl fumarate, Biogen Idec).

If and when the FDA or Novartis provide additional information or new advice for people taking Gilenya or other MS medications, the National MS Society will share it as soon as possible.

Learn more about the risk factors and identifying symptoms of PML from the web site of The PML Consortium.


Gilenya is a registered trademark of Novartis AG.
Tysabri is a registered trademark of Biogen Idec.
Tecfidera is a registered trademark of Biogen Idec.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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