Scenesse afamelanotide regulatory update

Clinuvel said that EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to a post-authorization safety study (PASS) protocol, which now allows the company to launch Scenesse afamelanotide to treat erythropoietic protoporphyria (EPP). The PASS protocol determines the collection of patient medical data and is part of an agreed upon risk management plan to monitor the safety of Scenesse. Clinuvel will provide periodic safety updates on the safety and use of Scenesse from data collected in a disease registry. ...