title: Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.
abstract: Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Segec
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: Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.|Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: N S
authors.initials: NS
authors.lastname: Vermeer
authors.affiliation: Agenzia Italiana del Farmaco (AIFA), Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Macchiarulo
authors.affiliation: Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: S M
authors.initials: SM
authors.lastname: Straus
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Hidalgo-Simon
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.|Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: M L
authors.initials: ML
authors.lastname: De Bruin
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects; D003657:Decision Making; D019468:Disease Management; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced* / Q000175:diagnosis / Q000628:therapy*; D018570:Risk Assessment / Q000379:methods
chemical_list: D061067:Antibodies, Monoclonal, Humanized