A Gilenya patient, without previous Tysabri exposure, has contracted progressive multifocal leukoencephalopathy (PML). Novartis has reported a case of PML 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.
Details of the case: The following key medical details have been sent to Novartis based on the data currently available:
http://www.novartis.com/newsroom/pro...y-update.shtml
Details of the 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 without the initiation of treatment with another therapy.
- In March 2010, the individual had another MS relapse.
- Treatment with Gilenya® began in Oct 2010 (he is currently participating in a Gilenya® non-interventional 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.
http://www.novartis.com/newsroom/pro...y-update.shtml
Comment