EMA & FDA Orphan Drug Designations: The Usual Suspects
While the both the EMA and FDA (Office of Orphan Products) has seen a substantial and consistent rise in orphan designation requests, and consequently an increase in the orphan designations for which they approve, the figures are not equivalent.
In the United States for instance, the OOPD designated 354 of the 466 applications received in 2015. In 2016, the OOPD received 110 more applications, setting a new record from the previous year, yet designated fewer (333). These numbers show designated applications dropping a whopping 20%.