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FDA Will Revise Label on Novartis' (NVS) Gilenya to Reflect Risk of Rare Brain Infection

August 4, 2015 2:40 PM EDT

The U.S. FDA issued the following announcement on Tuesday:

The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.

Patients taking Gilenya should contact their health care professionals right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance. Patients should not stop taking Gilenya without first discussing it with their health care professionals. Health care professionals should stop Gilenya and perform a diagnostic evaluation if PML is suspected.

Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce inflammation.

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs. Symptoms of PML are diverse and may include progressive weakness on one side of the body; clumsiness; vision problems; confusion, and changes in thinking, personality, memory and orientation. The progression of deficits can lead to severe disability or death. A magnetic resonance imaging (MRI) scan may find lesions in the brain before these symptoms develop.

In an August 2013 Drug Safety Communication, we reported that a patient developed PML after taking Gilenya. PML could not be conclusively linked to Gilenya in this case because prior to Gilenya treatment the patient had been treated with an immunosuppressant drug that can cause PML and during Gilenya treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

Gilenya’s manufacturer, Novartis (NYSE: NVS), recently notified FDA about one patient with PML and one patient with probable PML that occurred during Gilenya treatment without prior or concurrent exposure to other immunosuppressant drugs. The patient with probable PML did not have clinical signs or symptoms suggestive of PML, and was diagnosed based on MRI findings compatible with PML and JC virus detected in the cerebrospinal fluid (CSF). The other patient was diagnosed with definite PML based on characteristic symptoms, MRI findings, and JC virus in the CSF. Gilenya treatment was stopped in both patients (see Data Summary). Information describing these two cases has been added to the Warnings and Precautions and Patient Counseling Information sections of the drug label, as well as to the patient Medication Guide.

We urge health care professionals and patients to report side effects involving Gilenya to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.



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