title: Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators' perspective.
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.
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: R
authors.initials: R
authors.lastname: Anton
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: M
authors.initials: M
authors.lastname: Haas
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: P
authors.initials: P
authors.lastname: Arlett
authors.affiliation: Federal Institute for Drugs and Medical Devices, Bonn, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Weise
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: P
authors.initials: P
authors.lastname: Balabanov
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: G
authors.initials: G
authors.lastname: Mazzaglia
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: L
authors.initials: L
authors.lastname: Prieto
authors.affiliation: Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Keller-Stanislawski
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Raine
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects; D005060:Europe / Q000453:epidemiology; D005062:European Union; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects*; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced* / Q000453:epidemiology / Q000276:immunology; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D000069442:Natalizumab / Q000009:adverse effects; D018570:Risk Assessment / Q000331:legislation & jurisprudence; D012307:Risk Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069442:Natalizumab