Gilenya Labels to be Updated to Include Warnings for PML Cases

On August 4, 2014, the Food and Drug Administration (FDA) announced labels for Novartis’ Gilenya will be revised to include information about a case of progressive multifocal leukoencephalopathy (PML) and another probable case of PML. Gilenya is a treatment used for patients with relapsing forms of multiple sclerosis.

These are the first PML cases reported in patients who have not taken another immunosuppressant for MS or any other condition. In August 2013, the FDA did report a case where a patient developed PML after taking the treatment. However, the patient was also treated with other immunosuppressants in addition to Gilenya.

PML is a rare, opportunistic infection of the brain which causes severe damage to the white matter. It can occur in people who have weakened immune systems and have been infected with the John Cunningham (JC) virus. The JC virus is a common virus and harmless in most people except those with weakened immune systems.

Patients taking the treatment should contact their doctor immediately if they experience symptoms including new or worsening weakness, increased issues using arms or legs, or changes in cognitive function, vision, strength or balance. Patients should not stop taking the treatment until they discuss with their doctor. The FDA also urges healthcare professionals and patients to report any side effects from the treatment to the FDA MedWatch.

Gilenya was approved for use in the United States in 2010 and in Europe in 2011. Label revisions also occurred in Biogen Idec’s Tecfidera in November 2014 and Biogen Idec's Tysabri in 2009.1,2

For more information regarding updates to Gilenya’s label, visit the FDA’s announcement.

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