Novartis AG announced on Friday that a patient taking its Gilenya pill for multiple sclerosis had developed a serious, life-threatening brain infection called progressive multifocal leukoencephalopathy, or PML. According The Wall Street Journal, the report will likely raise more questions about the safety of Gilenya, which last year attracted scrutiny after some patients died within 24 hours of taking their first dose of Gilenya.
In a statement issued Friday, Novartis pointed out that the patient in question had previously been treated with Tysabri, an IV-administered multiple sclerosis drug already known to be associated with PML.
“The current assessment is that Tysabri is the drug most likely associated with this case of PML,” Novartis said. “However, a contribution of Gilenya to the evolution of this case can’t be excluded. Novartis said it doesn’t know of any confirmed PML cases in patients treated with Gilenya who hadn’t previously been treated with Tysabri.
Gilenya received U.S. regulatory approval September 2010. In December 2011, the U.S. Food & Drug Administration (FDA) after a patient died within 24 hours of taking his/her first dose of Gilenya. European Medicines Agency (EMA) regulators started their own review in February, after receiving reports of 10 additional deaths among Gilenya patients. According to Novartis AG, six deaths were unexplained, three resulted from heart attacks, and one was due to disruption of heart rhythm.
Earlier this month, the Institute for Safe Medication Practices (ISMP) called for the FDA to restrict use of the drug and improve its patient monitoring. The ISMP based its request on a review of adverse events reported to the FDA in the second quarter of last year. According to the group’s latest Quarter Watch report, of 286 Gilenya adverse event reports received by the FDA, 60 involved retinal injuries and other adverse vision effects; 68 involved infection reports at various areas of the body, eye, skin, urinary tract, and upper respiratory tracts; and a number of vascular-related adverse effects including 16 blackouts or syncope, 27 reductions in blood pressure, slow heart rate, or bradycardia, and 10 cases of peripheral edema.