Clinuvel's Scenesse gets EMA nod in EPP

Shares in Clinuvel (ASX:CUV) climbed more than 70% after the EMA approved the company’s Scenesse drug in adult patients with rare skin disorder erythropoietic protoporphyria (EPP).

The European agency’s Committee for Medicinal Products for Human Use has voted in favour of marketing authorisation for the drug, paving the way for its distribution across 31 European states.

Clinuvel and the EMA have agreed to a post-authorisation pharmacovigilance plan to monitor patients’ long-term safety.

EPP is a rare and severe genetic disorder characterised by a painful intolerance to light and UV. It affects around 10,000 patients worldwide, including around 4500 in Europe.

Scenesse is an injectable controlled-release implant designed to deliver 16 mg of afamelanotide. The drug is used to activate eumelanin, the skin’s dark pigment, in affected patients. Clinuvel is also trialling the drug in vitiligo.

“Today’s EMA outcome is a landmark achievement by Clinuvel and all those who worked with this program for nearly a decade,” Clinuvel Acting Chief Scientific Officer Dr Dennis Wright said.

“The life of a patient with EPP is one of social deprivation, punctuated by periods of second degree burns and unspeakable pain following exposure to daylight or bright indoor lighting. For a decade now my team remained motivated by the unique opportunity to provide a product that could be life altering for these patients.”

Clinuvel (ASX:CUV) shares were trading 71.76% higher at $4.50 as of around 2.30 pm on Monday.