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Strategy in Regulatory Decision‐Making for Management of Progressive Multifocal Leukoencephalopathy
Author(s) -
Segec A,
KellerStanislawski B,
Vermeer NS,
Macchiarulo C,
Straus SM,
HidalgoSimon A,
De Bruin ML
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.199
Subject(s) - pharmacovigilance , progressive multifocal leukoencephalopathy , medicine , intensive care medicine , leukoencephalopathy , agency (philosophy) , regulatory agency , adverse effect , pharmacology , pathology , political science , immunology , disease , philosophy , epistemology , public administration , multiple sclerosis
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.