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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).

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