ARTICLE | Politics & Policy

EMA piloting patient input in MAA reviews

September 26, 2014 4:18 PM UTC

EMA announced the start of a pilot program to integrate patient discussion of drug benefit-risk into the assessment of MAAs or into decisions on whether to withdraw or restrict access to approved products.

In Scenesse afamelanotide ( CUV1647) from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Two patients shared their experiences of EPP with CHMP and answered questions from the committee. Their comments will be considered during the MAA review of Scenesse. ...