Clinuvel gets orphan status for Scenesse in US too

Hot on the heels of securing orphan drug status in the EU for its drug Scenesse in Hailey-Hailey disease (HHD), Clinuvel Pharmaceuticals (ASX:CUV) has been awarded the designation in the US as well.

The US FDA has granted orphan drug designation to Scenesse in the rare skin disorder, paving the way for seven years of market exclusivity if the drug is approved for marketing.

Orphan status will also entitle Clinuvel to technical assistance through the development process, potential fee reductions and tax credits.

The announcement came the same week the European Medicines Agency awarded the drug orphan designation in the EU.

“[The EMA’s] designation is the second from a major regulatory agency to recognise the potential of afamelanotide to treat HHD patients, who currently lack an effective therapy,” Clinuvel acting Chief Scientific Officer Dr Dennis Wright said. Afamelanotide is the generic name for Scenesse.

“We are encouraged by the regulatory support to date and now await the outcomes of the Phase II study.”

The trial commenced in Italy in February. It aims to treat 10 HHD patients with 12 doses of Scenesse over a one-year period.

HHD is a rare genetic disorder affecting epidermal skin cells, characterised by periodic eruptions of plaque-like legions, blisters and ulcerations on skin folds.

Clinuvel (ASX:CUV) shares were trading 4.79% higher at $1.53 as of around 1.30 pm on Thursday.