Orphan drug kicks off EMA project to involve patients in benefit-risk assessments
This article was originally published in SRA
Executive Summary
In a move intended to give patients more of a say in the evaluation of new drugs, the European Medicines Agency has begun a project under which patients will be invited to take part in certain benefit-risk discussions at meetings of its main scientific committee, the CHMP1,2. The project has kicked off with Clinuvel's Scenesse (afamelanotide), a new drug intended to treat the rare disease erythropoietic protoporphyria (EPP).