EU panel recommends approval of Clinuvel's sunburn-prevention drug
- Scenesse (afamelanotide) was developed by the Australian company, Clinuvel, for prevention of severe sunburn in patients with a rare genetic disease—erythropoietic protopophyria (EEP)—which renders patients intolerant to light.
- The Committee for Medicinal Products for Human Use (CHMP) recommended European Medicines Agency (EMA) approval of Scenesse.
- The CHMP recommends that approval be contingent on a risk-management plan to monitor safety and efficacy aggressively during the post-marketing phase.
Scenesse is part of a new class of drugs called melanocortins that functions as an antioxidant and activates melanin in the skin, providing a biological barrier against the sun. EEP patients face extreme pain, scarring and swelling, simply by encountering even a minimal amount of sunlight. They literally are forced to live in the shadows. A clinical trial involving 350 patients with EEP showed reduced incidence and severity of negative reactions to light, with a relatively high level of tolerability to Scenesse. This drug is considered a life-changing medication that will significantly improve quality of life for EEP patients.
- pharmafile.com Scenesse recommended for rare sun disease in Europe