Published April 13, 2012
The Wall Street Journal
BASEL, Switzerland – Novartis said Friday a patient treated with its multiple sclerosis (MS) pill Gilenya was diagnosed with a rare and often fatal brain disease.
The Swiss drugmaker said the patient, whose identity was not disclosed, previously was treated with another MS drug, Tysabri, co-marketed by Biogen Idec and Elan, which already was associated with progressive multifocal leukoencephalopathy (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.”
The development comes at a critical time for Novartis’ Gilenya, whose safety profile recently came into question after the death of one person in the US last fall within 24 hours of starting treatment. Heart problems in some patients also were reported.
The European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago, is expected to issue a decision on the safety of the medicine April 20 following an in-depth review.
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