Label of Novartis' Gilenya to be updated after FDA warns of PML cases

The FDA on Tuesday announced that the label for Novartis' Gilenya (fingolimod) will be revised after the multiple sclerosis (MS) drug was linked to cases of progressive multifocal leukoencephalopathy (PML). Specifically, the label revision will include information about a case of definite PML and another of probable PML that have been reported in MS patients taking the therapy. The agency noted that these are the first PML cases in patients taking Gilenya who had not previously received an immunosuppressant for MS or any other condition.

The agency, which was recently notified of the cases by Novartis, noted that the patient with probable PML did not exhibit clinical signs or symptoms of the brain infection, and was diagnosed based on MRI findings and viral detection in the cerebrospinal fluid. The definite case of PML was diagnosed based on characteristic symptoms, as well as MRI and viral detection. The agency added that treatment with Gilenya was halted in both patients.

In 2013, Novartis reported that a patient who had been taking Gilenya for several months developed PML, with the FDA later issuing a safety communication that it was investigating the matter. However, the agency concluded that the infection could not be conclusively linked to Gilenya as the patient had been given an immunosuppressant drug that can cause PML, in addition to multiple courses of intravenous corticosteroids during Gilenya treatment.

Meanwhile, the label of Biogen Idec's MS therapy Tecfidera (dimethyl fumarate) was updated last November after the FDA warned of a fatal PML case involving a patient who had not been taking other therapies that affect the immune system or treatments believed to be associated with the brain infection. A label revision was also made for Biogen Idec's Tysabri (natalizumab) in 2009 to describe that the risk of PML increases with prolonged use of the therapy.

Gilenya, which was cleared by regulators in the US in 2010 and in the EU the following year, amassed $700 million in revenue in the quarter ended June 30.

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