Repurposing existing medicines for new therapeutic uses may help address unmet medical needs. Moreover, development times and costs of repurposing a medicine can be reduced compared with de novo development. Nonetheless, the commercial incentive to pursue an extension of an indication for a marketed product may be limited, in particular when the intended patient population is small (such as for rare diseases) or when medicines are off-patent. In such cases, academic researchers, hospital physicians and patient organizations can play an important role in finding new uses for existing medicines.
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Acknowledgements
We thank the many people at the different agencies supporting this pilot. Specifically, we thank the coordinators from the Scientific Advice Working Party (SAWP) who were involved in this project and colleagues from EMA’s scientific advice, real-world evidence, methodology, academia and regulatory affairs offices. We thank R. Ruano, J. Ruiz, T. Arroyo for their contributions to AEMPS advice during the pilot, T. Girard and I. Gravanis for their support to perform this pilot and their review of this manuscript, and G. Borg for his work on data collection and developing the figures. We thank F. Pignatti and J. Jansen for their comments and support in drafting this manuscript.
Disclaimer
The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
Competing Interests
The authors declare no competing interests.