ARTICLE | Clinical News

Scenesse afamelanotide regulatory update

September 29, 2014 7:00 AM UTC

EMA selected Scenesse afamelanotide from Clinuvel for prophylactic treatment of erythropoietic protoporphyria (EPP) as the first product to be included in its pilot project to involve patients in CHMP's assessment of benefits and risks. EMA said the project will run for at least 1 year to assess the feasibility of involving patients in CHMP oral explanations. An MAA for Scenesse is under EMA review.

As part of the project, patients will be invited to present their views on drugs for which there is an unmet medical need and for which CHMP has concerns or doubts. Patients will also be invited to give their views on cases in which CHMP is considering to recommend withdrawal, suspension or revocation of an MAA or a restriction of indication. EMA said 2 patients with EPP shared their experiences and answered questions from CHMP during its meeting earlier this month to discuss the MAA for Scenesse. ...