EMA and HMA launch pilot to support repurposing of medicines

Article summary

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have launched a pilot to support not-for-profit organisations and academia with the repurposing of medicines following the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) proposal for a medicines repurposing framework. The aim of this initiative is outlined as gathering or generating sufficient evidence on the use of established medicine in a new indication to then have the new use authorised by a regulatory authority. The EMA and national medicines agencies are highlighted to provide regulatory support as part of the pilot to help stakeholders generate a data package robust enough to support an application by a pharmaceutical company. EMA lays out criteria that candidate medicines should fulfil for the pilot including containing a well-established active substance, being an authorised medicine no longer protected by data exclusivity or a patent, and targeting an indication in a condition distinct from the authorised indication currently....