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news.Australia-based Clinuvel Pharmaceuticals has received regulatory approval from the European Medicines Agency (EMA) for its Scenesse (afamelanotide 16mg) drug to treat adult patients with rare skin disorder erythropoietic protoporphyria (EPP).
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EPP is characterized by an extreme risk of severe burns of the skin resulting in intolerable pain, swelling, scarring and a state of distress.
The company said that Scenesse acts as an anti-oxidant and activates melanin in skin and is the first treatment ever to have been developed for this rare skin disorder.
The approval is based on clinical trials carried out in 350 adult EPP patients have shown the drug to be well tolerated, to reduce the incidence and severity of reactions.
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."
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Scenesse be approved under exceptional circumstances (EC), which will enable the company to market the drug for EPP across the European states.
Under the EC approval, the company and EMA have agreed to a comprehensive post-authorization pharmacovigilance plan to follow up patients.