Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

A Segec; B Keller-Stanislawski; N S Vermeer; C Macchiarulo; S M Straus; A Hidalgo-Simon; M L De Bruin

doi:10.1002/cpt.199

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

A Segec, B Keller-Stanislawski, N S Vermeer, C Macchiarulo, S M Straus, A Hidalgo-Simon, M L De Bruin

3 Citations (Scopus)

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.

Original language	English
Journal	Clinical Pharmacology and Therapeutics
Volume	98
Issue number	5
Pages (from-to)	502-5
Number of pages	4
ISSN	0009-9236
DOIs	https://doi.org/10.1002/cpt.199
Publication status	Published - 1 Nov 2015
Externally published	Yes

Keywords

Antibodies, Monoclonal, Humanized
Decision Making
Disease Management
Drug-Related Side Effects and Adverse Reactions
Humans
Leukoencephalopathy, Progressive Multifocal
Risk Assessment
Journal Article
Review

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10.1002/cpt.199

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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.",

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AU - Segec, A

AU - Keller-Stanislawski, B

AU - Vermeer, N S

AU - Macchiarulo, C

AU - Straus, S M

AU - Hidalgo-Simon, A

AU - De Bruin, M L

PY - 2015/11/1

Y1 - 2015/11/1

N2 - 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.

AB - 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.

KW - Antibodies, Monoclonal, Humanized

KW - Decision Making

KW - Disease Management

KW - Drug-Related Side Effects and Adverse Reactions

KW - Humans

KW - Leukoencephalopathy, Progressive Multifocal

KW - Risk Assessment

KW - Journal Article

KW - Review

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VL - 98

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JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 5

ER -

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

Abstract

Keywords

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