Progressive multifocal leukoencephalopathy (PML) has been associated with the use of a number of multiple sclerosis (MS) immunomodulatory therapies and has assumed a critical place in the evaluation of their benefit/risk. In this review, we discuss the European Union regulatory approach to drug-induced PML in MS, highlight a number of key issues related to the current knowledge on PML, and outline possible paths to help progress the risk management of patients with MS at risk of PML.
Anton, R., Haas, M., Arlett, P., Weise, M., Balabanov, P., Mazzaglia, G., et al. (2017). Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators' perspective. CLINICAL PHARMACOLOGY & THERAPEUTICS, 102(2), 283-289 [10.1002/cpt.604].
Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators' perspective
Mazzaglia, G;
2017
Abstract
Progressive multifocal leukoencephalopathy (PML) has been associated with the use of a number of multiple sclerosis (MS) immunomodulatory therapies and has assumed a critical place in the evaluation of their benefit/risk. In this review, we discuss the European Union regulatory approach to drug-induced PML in MS, highlight a number of key issues related to the current knowledge on PML, and outline possible paths to help progress the risk management of patients with MS at risk of PML.
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