Novartis has been informed of a progressive multifocal leukoencephalopathy (PML) diagnosis in a JCV antibody positive MS patient who had previously been treated with Tysabri® (natalizumab) for approximately three and a half years prior to initiating treatment with Gilenya (fingolimod).
is a known risk of PML associated with natalizumab treatment,
especially in patients who are JCV antibody positive and have been
treated with natalizumab for more than two years. The current assessment
is that natalizumab is the drug most likely associated with this case
of PML. However, a contribution of Gilenya to the evolution of this case
cannot be excluded.
This is the first reported PML case in
approximately 36,000 fingolimod-treated patients, of whom approximately
2,400 were treated for more than two years and approximately 500 were
treated for more than four years. There is currently no confirmed case
of PML reported to Novartis in a fingolimod-treated patient without
previous natalizumab treatment.
Details on the case are being submitted to heath authorities according to regulations as they become available.
Novartis believes Gilenya is a benefit for appropriate MS patients when used in accordance with approved labeling.