UPDATE: The FDA has released a safety communication regarding cases of PML in people taking Gilenya, described below. Read more

Read the updated prescribing information and patient medication guide.

June 9, 2015

Novartis has confirmed that it has received a report of a second case of PML (progressive multifocal leukoencephalopathy, a rare viral infection of the brain that often leads to death or severe disability) in a person with MS taking Gilenya® (fingolimod, Novartis AG). According to the company’s statement, this individual had been on Gilenya since the end of 2012, and has been hospitalized. The company has reported this case to the U.S. Food and Drug Administration (FDA) and other health authorities.

There have been two previous cases of PML involving a person taking Gilenya. The most recent was reported in February 2015 and involved someone with MS. The first case of PML in a person taking Gilenya was reported August 2013. According to Novartis, this individual had Neuromyelitis Optica spectrum disorder (NMO) and not multiple sclerosis.



PML is caused by the re-activation of a virus called the JC (John Cunningham) virus, a common virus to which many people have been exposed. PML has emerged in people using other medications, including the MS treatment Tysabri (natalizumab, Biogen), and the MS treatment Tecfidera (dimethyl fumarate, Biogen).



It is not possible at this point to determine a person’s risk for developing PML because there have been so few cases in people taking Gilenya. There have been two reported cases of PML in people with MS among the more than 119,000 individuals who have been treated with Gilenya to date.



The symptoms of PML are diverse and can be similar to MS symptoms. For this reason individuals should be alert to any new or worsening symptoms and report them promptly to their MS healthcare provider.



Learn more about PML from the website of the National Insitutes of Health. Individuals who have concerns about this report should discuss it with their MS healthcare providers.



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

Gilenya is a registered trademark of Novartis AG.

Tysabri is a registered trademark of Biogen.

Tecfidera is a registered trademark of Biogen.

