A new REMEDi4ALL publication in Nature Reviews Drug Discovery contributes to the ongoing discussion on how to better support medicines repurposing in Europe. The work responds to an earlier publication on the EU pilot framework developed under the STAMP (Stimulating medicines repurposing in the EU: a pilot project) initiative.
The article reflects on the outcomes and implications of the EU repurposing pilot launched by the European Medicines Agency (EMA) and national authorities. The pilot, originally proposed within the European Commission’s STAMP expert group, aims to support not-for-profit organisations and academic researchers in generating the evidence needed to bring new therapeutic uses of existing medicines to patients.
By offering tailored scientific advice to selected “champion” projects, the pilot has explored how regulatory support can bridge gaps between academic research and formal authorisation pathways for repurposed medicines.
Within this context, the publication also highlights REMEDi4ALL’s role in supporting translation from evidence to approval. Acting as a neutral “honest broker”, REMEDi4ALL facilitated collaboration between academic researchers and a marketing authorisation holder (MAH) in a STAMP pilot case, helping establish a pathway towards label extension of an oncology drug for a rare immune disorder. This included providing hands-on regulatory support, preparing the academic team for EMA scientific advice procedures, and supporting engagement with the MAH to advance the project towards registration.
Authors from the REMEDi4ALL consortium underline the value of this approach while recognising persistent challenges in translating promising repurposing opportunities into authorised treatments including: scalability and sustainability of support; health technology assessment procedures; post-marketing pharmacovigilance; and requirement of complex multistakeholder interactions including between academics and MAHs despite new EU pharmaceutical legislation.
“To fully realise the potential of drug repurposing, EU policies and programmes, like STAMP, must expand to encompass all key stakeholders — public and commercial — to enable new treatment opportunities to advance all the way through to patient access.”
These findings align closely with REMEDi4ALL’s mission to advance patient-centric drug repurposing in Europe. As an EU-funded platform bringing together academia, clinicians, patients and regulators, REMEDi4ALL contributes to strengthening the ecosystem needed to support high-impact repurposing projects and address unmet medical needs.
Through involvement in initiatives such as the STAMP pilot, REMEDi4ALL continues to promote collaboration, evidence generation and policy dialogue to help translate repurposing research into accessible treatment options for patients across Europe.
