Case of PML reported in patient treated with Gilenya®

Updated April 8, 2015

Pharmaceutical company Novartis has reported a case of PML (progressive multifocal leukoencephalopathy) in an individual who had received Gilenya®* (fingolimod) for more than 4 years for the treatment of relapsing-remitting multiple sclerosis (RRMS). Novartis has informed the regulatory authorities of this case, and is investigating whether treatment with Gilenya® contributed to the development of PML.

About Gilenya®

Gilenya® was approved by Health Canada in 2011 as the first oral disease-modifying therapy for MS. Gilenya® is generally prescribed to individuals who have tried one or more MS therapies, but are unresponsive or intolerant to them. It is also indicated for use as a monotherapy for the treatment of people with RRMS to reduce frequency of relapses and delay progression of disability. Approval of Gilenya® was based on data from two large-scale clinical trials involving over 1,200 participants.

Gilenya® is an oral capsule taken once a day. It is believed to act by retaining white blood cells in the lymph nodes, preventing entry of these cells into the central nervous system where they would promote inflammatory damage to nerves.


This is the first case of PML observed for Gilenya® in an individual with multiple sclerosis who had not been previously treated with Tysabri®. In 2012 Novartis reported a case of PML in a patient that was taking Gilenya®, noting that the PML was likely associated with previous treatment with Tysabri®.

In 2013, a patient developed PML following treatment with Gilenya® according to a statement from Novartis, this individual’s underlying disease was an aggressive form of Neuromyelitis Optica spectrum disorder (NMO) and not multiple sclerosis. A definite link between PML and Gilenya® in this person has not been established.

About progressive multifocal leukoencephalopathy

PML is a rare, generally fatal brain disease caused by the JC virus. It is primarily associated with severely suppressed immune systems. Symptoms of PML can include: progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion and personality changes.

Learn more about PML here.

Details of the 2015 case

The following key medical details have been sent to Novartis based on the data currently available:

  • 49 year old male who first experienced MS symptoms in Oct 2009 and was diagnosed with RRMS in Nov 2009.
  • The individual began treatment with Rebif®, which was discontinued in September 2010 without the initiation of treatment with another therapy.
  • In March 2010, the individual had another MS relapse.
  • Treatment with Gilenya® began in Oct 2010 (and was then participating in an observational study). There were no reported co-existing conditions, nor was he taking any other medications during treatment with Gilenya®. He had never received treatment with Tysabri.
  • A routine MRI evaluation performed in January 2015 detected several lesions which were considered unusual for MS and compatible with a diagnosis of PML. The individual tested positive for JC virus, confirming the diagnosis.
  • The patient is currently doing well. Gilenya® was discontinued.


The positive benefit-risk profile of Gilenya® in RRMS is based on information collected from 114,000 patients treated with Gilenya®, more than 195,000 patient years as well as related real-world efficacy and safety data. Novartis has stated that the current understanding of the mechanism of action of Gilenya® does not explain a causal relationship between the drug and PML in this individual. The MS Society will provide any updates that become available as Novartis continues to evaluate the case further.

*Gilenya® is a registered trademark of Novartis