Good news: EMA supports pilot project for repurposing of authorised medicines
Brussels - As an acknowledged leader in drug repurposing to treat cancer, the Anticancer Fund welcomes the initiative of the European Medicines Agency (EMA) to support a pilot project for research conducted by non-profit-organisations and academia who want to gather evidence on the use of existing drugs in a new indication.
Repurposing of medicines, or identifying new uses for an authorised medicine, has been a focus area of the Anticancer Fund for years. We are very glad that EMA and the national medicines agencies are now ready to provide regulatory support, especially scientific advice, to not-for-profit organisations and academia who are willing to investigate existing drugs for new indications.
The Anticancer Fund has been involved in the early developments of a policy framework for drug repurposing at European level. Our managing director Lydie Meheus and collaborator Ciska Verbaanderd contributed to the Expert Group of the European Commission on the Safe and Timely Access to Medicines for Patients (STAMP), that urged EMA, representatives of the Member States, healthcare professionals, industry and health technology assessment bodies to set up a pilot project that would make regulatory progress for drug repurposing possible.
As part of the pilot project, EMA and national medicines agencies will help not-for-profit organisations and academia (institutions and individuals) to generate a robust data package, ready for application by a pharmaceutical company. The stakeholders willing to apply can do so by 28 February 2022.
“This pilot project is a step in the right direction. It aims to help clinicians and researchers to generate the necessary data from the regulators' perspective. The ultimate change patients, doctors and societies need is to ensure that all robust new uses of generic drugs systematically get on the drug's label. The pilot project can unfortunately not solve the pressing problem of generic drugs being used off-label despite robust evidence, but it is a great sign that regulators and companies want to work towards this end.”, says Gauthier Bouche, director clinical research of the Anticancer Fund.
Making new treatment options available
In order to coordinate the pilot, the STAMP working group has organised an observatory group, so called Repurposing Observatory Group (RepOG), composed of regulatory representatives, the European Commission, interest groups and industry.
The Anticancer Fund believes repurposing existing medicines offers a safe, effective and affordable way to increase patients’ treatment options. We have been tracking the research in this domain and have listed non-cancer drugs with published evidence of anticancer effects. Today this database contains more than 300 drugs which can be further investigated in clinical research. Next to this, the Anticancer Fund created a database of clinical trials with repurposed drugs in oncology, the only free available database with this information so far. We curated more than 800 active trials with potential cancer treatments.