Drug repurposing for inclusion of COVID-19-related indication: field study of the European Medicines Agency’s response to the pandemic

As one of the biggest challenges for healthcare in the 21st century, COVID-19 placed a sustained and intense demand on the European Medicines Agency resources and required constant adaptation and mobilization of different regulatory processes. In this situation drug repurposing appeared as a promising potential approach in quickly emerging health crises due to its main advantage of reducing time and cost for addition of new indications since it uses products proven to be of high quality, safe and effective. The European Medicines Agency authorised total of 8 products for the SARS-CoV-2 infection, 3 (37.5%) of which used this mechanism for development (Veklury, RoActemra and Kineret). The application of drug repurposing by these medicines highlights the importance of the life cycle stage at which repositioning is undertaken. This resulted in different volumes of data submitted in the respective European Public Assessment Reports. The participation of organisations other than the MAH in key stages in the drug development process of repurposed products once again shows the need to regulate this interaction.