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Repurposing of Medicines in the EU: Launch of a Pilot Framework

Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing medicine in an indication outside the scope of the original approved indication. Indeed, the COVID-19 health crisis has brought the concept to the f...

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Autores principales: Asker-Hagelberg, Charlotte, Boran, Tomas, Bouygues, Christelle, Eskola, Sini Marika, Helmle, Laszlo, Hernández, César, Houýez, François, Lee, Helen, Lingri, Dimitra D., Louette, Laurent, Meheus, Lydie, Penninckx, Wim, Stepniewska, Beata
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8784735/
https://www.ncbi.nlm.nih.gov/pubmed/35083258
http://dx.doi.org/10.3389/fmed.2021.817663
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author Asker-Hagelberg, Charlotte
Boran, Tomas
Bouygues, Christelle
Eskola, Sini Marika
Helmle, Laszlo
Hernández, César
Houýez, François
Lee, Helen
Lingri, Dimitra D.
Louette, Laurent
Meheus, Lydie
Penninckx, Wim
Stepniewska, Beata
author_facet Asker-Hagelberg, Charlotte
Boran, Tomas
Bouygues, Christelle
Eskola, Sini Marika
Helmle, Laszlo
Hernández, César
Houýez, François
Lee, Helen
Lingri, Dimitra D.
Louette, Laurent
Meheus, Lydie
Penninckx, Wim
Stepniewska, Beata
author_sort Asker-Hagelberg, Charlotte
collection PubMed
description Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing medicine in an indication outside the scope of the original approved indication. Indeed, the COVID-19 health crisis has brought the concept to the frontline by proving the usefulness of this practise in favour of patients for an early access to treatment. Under the umbrella of the Pharmaceutical Committee and as a result of the discussions at the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) a virtual Repurposing Observatory Group (RepOG) was set up in 2019 to define and test the practical aspects of a pilot project thought to provide support to “not-for-profit” stakeholders generating or gathering data for a new therapeutic use for an authorised medicine. The group's initial plan was impacted by the outbreak of the SARS-CoV-2 pandemic and the launch of the pilot needed to be postponed. This article describes the progress and the activities conducted by the group during this past and yet extraordinary 2020–2021 to keep the project alive and explores on the background of this topic together with the obvious opportunities this health crisis has brought up in terms of repurposing of medicines.
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spelling pubmed-87847352022-01-25 Repurposing of Medicines in the EU: Launch of a Pilot Framework Asker-Hagelberg, Charlotte Boran, Tomas Bouygues, Christelle Eskola, Sini Marika Helmle, Laszlo Hernández, César Houýez, François Lee, Helen Lingri, Dimitra D. Louette, Laurent Meheus, Lydie Penninckx, Wim Stepniewska, Beata Front Med (Lausanne) Medicine Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing medicine in an indication outside the scope of the original approved indication. Indeed, the COVID-19 health crisis has brought the concept to the frontline by proving the usefulness of this practise in favour of patients for an early access to treatment. Under the umbrella of the Pharmaceutical Committee and as a result of the discussions at the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) a virtual Repurposing Observatory Group (RepOG) was set up in 2019 to define and test the practical aspects of a pilot project thought to provide support to “not-for-profit” stakeholders generating or gathering data for a new therapeutic use for an authorised medicine. The group's initial plan was impacted by the outbreak of the SARS-CoV-2 pandemic and the launch of the pilot needed to be postponed. This article describes the progress and the activities conducted by the group during this past and yet extraordinary 2020–2021 to keep the project alive and explores on the background of this topic together with the obvious opportunities this health crisis has brought up in terms of repurposing of medicines. Frontiers Media S.A. 2022-01-10 /pmc/articles/PMC8784735/ /pubmed/35083258 http://dx.doi.org/10.3389/fmed.2021.817663 Text en Copyright © 2022 Asker-Hagelberg, Boran, Bouygues, Eskola, Helmle, Hernández, Houýez, Lee, Lingri, Louette, Meheus, Penninckx and Stepniewska. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Asker-Hagelberg, Charlotte
Boran, Tomas
Bouygues, Christelle
Eskola, Sini Marika
Helmle, Laszlo
Hernández, César
Houýez, François
Lee, Helen
Lingri, Dimitra D.
Louette, Laurent
Meheus, Lydie
Penninckx, Wim
Stepniewska, Beata
Repurposing of Medicines in the EU: Launch of a Pilot Framework
title Repurposing of Medicines in the EU: Launch of a Pilot Framework
title_full Repurposing of Medicines in the EU: Launch of a Pilot Framework
title_fullStr Repurposing of Medicines in the EU: Launch of a Pilot Framework
title_full_unstemmed Repurposing of Medicines in the EU: Launch of a Pilot Framework
title_short Repurposing of Medicines in the EU: Launch of a Pilot Framework
title_sort repurposing of medicines in the eu: launch of a pilot framework
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8784735/
https://www.ncbi.nlm.nih.gov/pubmed/35083258
http://dx.doi.org/10.3389/fmed.2021.817663
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