[PSY101] Orphan Drug Approvals In Europe: Historical Review and Trends

[PSY101] Orphan Drug Approvals In Europe: Historical Review and Trends

2014 Value in health

Rodrigues, J. | Korchagina, D. | Remuzat, C. | Brunet, J. | Tavella, F. | Volume: 17, Issue: 7, Pages: A539, Europe, orphan drug, trends, Value,

In Europe, orphan designation has been granted by European Medicines Agency since 2000. Molecules with orphan designation can benefit from a number of incentives to guarantee return on investment for manufacturers. Since introduction of orphan legislation, the number of Orphan Drugs (OD) has significantly increased. In 2012, total OD sales reached 13% of the whole pharmaceutical market. This study aims to analyse current situation and trends in OD approvals.

https://www.doi.org/10.1016/j.jval.2014.08.1731; 10.1016/j.jval.2014.08.1731