COMP adopts positive opinion for 16 orphans
This article was originally published in Scrip
Executive Summary
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has adopted 16 positive opinions at its May meeting. Of these, six were adopted following a second discussion by the committee after the sponsoring company had responded to questions, and the other 10 were after their first consideration. The positive opinions constitute recommendations to the EMA, and are neither final decisions granting drugs EU orphan drug designation (these decisions are usually adopted within the space of a few weeks) nor are they recommendations for marketing authorisation.