On October 28th 2021, the European Medicines Agency launched a pilot project on repurposing. This pilot, which was first announced as one of the initiatives under the Pharmaceutical Strategy for Europe, aims to generate data packages to allow expanding the indications of medicines that are currently used off-label to treat other illnesses. It builds on the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework.
The initiative aims to support not-for-profit organizations and academia who have shown a particular interest in repurposing an authorized medicine for a new indication in an area of public health interest. The evidence generated would then be used to support an application from the current marketing authorization holder (MAH) for a new use that can then be formally authorized by a participating regulatory authority. To give a more concrete example, this means that a generic drug used outside of its approved marketed indication to treat another disease could be included in the pilot in order to generate additional data on this off-label use and eventually obtain a marketing authorization.
The EMA and national medicines agencies will provide regulatory support, primarily through scientific advice, to help these stakeholders generate a data package robust enough to support a future application by a pharmaceutical company.
The pilot is planned to run until the completion of the scientific advice for the selected repurposing candidate projects and possibly until the filing of an application by a pharmaceutical company for the new indication.