Evidence map›Paper›PMID 35083258›Full record

ArticleFrontiers in medicine2021

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

Charlotte Asker-Hagelberg, Tomas Boran, Christelle Bouygues, Sini Marika Eskola, Laszlo Helmle, César Hernández, François Houýez, Helen Lee, Dimitra D Lingri, Laurent Louette and 3 more

Abstract read
In one paragraph

Article in Frontiers in medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2024
    Article
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Charlotte Asker-HagelbergSwedish Medical Products Agency, Uppsala, Sweden.
Tomas BoranDirector of the Marketing Authorisation Section, State Institute for Drug Control (SUKL), Prague, Czechia.
Christelle BouyguesRegulatory Affairs Office, Human Medicines Division, European Medicines Agency (EMA), Amsterdam, Netherlands.
Sini Marika EskolaEuropean Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium.
Laszlo HelmleEuropean Commission Directorate-General Research and Innovation, Brussels, Belgium.
César HernándezAlternate Representative of Spain in EMA Management Board, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
François HouýezTreatment Information and Access, European Organisation for Rare Diseases (Eurordis), Paris, France.
Helen LeeEuropean Commission Directorate-General for Health and Food Safety, Brussels, Belgium.
Dimitra D LingriAssociation Internationale de la Mutualité Pharmaceutical Working Group, Brussels, Belgium.
Laurent LouetteEuropean Confederation of Pharmaceutical Entrepreneurs, Brussels, Belgium.
Lydie MeheusAnticancer Fund, Appointed Alternate of the Committee for Advanced Therapies of the European Medicines Agency (CAT/EMA) to Represent Patients, Strombeek-Bever, Belgium.
Wim PenninckxFederal Agency of Medicines and Health Products (FAMHP), Brussels, Belgium.
Beata StepniewskaMedicines for Europe, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

COVID-19European Unionoff patent authorised medicinespatient accesspilot launchrepurposingrepurposing observatory group

Identifiers

PMID35083258
PMCPMC8784735

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.