Clinuvel’s EU application for Scenesse delayed

The European Medicines Agency (EMA) has delayed its decision on whether to approve Clinuvel’s (ASX:CUV) Scenesse as a treatment for rare skin disease EPP.

The regulator has requested more time to evaluate Clinuvel’s marketing authorisation application for the treatment candidate.

Clinuvel has advised that the evaluation process will now continue past end-June and the company now expects a decision from the EMA in 2H13.

The EMA granted Clinuvel orphan drug status for Scenesse as an EPP treatment in 2008. Clinuvel filed for marketing approval in Europe in February 2012.

Clinuvel acting CSO Dr Dennis Wright downplayed the significance of the delay. “It is not unusual for a first-in-class drug and first-line therapy to be subject to a lengthy review,” he said.

In a separate newsletter for shareholders, CEO Philippe Wogan said the company is “confident that Scenesse offers the clinical solution for EPP patients.”

But he added that Clinuvel is unable to speculate about the EMA’s eventual decision, because regulators strongly urge drug sponsors not to publish speculative information before the review process is complete.

EPP (erythropoietic protoporphyria) is a rare skin disease characterised by painful oversensitivity to light. Scenesse is designed to activate eumelanin - a dark pigment - in the skin to help patients build up a tolerance.

As well as its EMA application, Clinuvel is also seeking FDA approval in the US. In May last year, the company commenced a final US phase III trial in EPP to accompany its submission.

Scenesse is also researching using Clinuvel to treat vitiligo and as a photoprotective for organ-transplant recipients.

Clinuvel shares were trading 0.96% higher at $2.10 as of around 2.30 pm on Tuesday.