EU backs drug for rare sun intolerance from Australia’s Clinuvel

EU backs drug for rare sun intolerance from Australia’s Clinuvel

(Reuters) – European patients with a rare genetic disease that causes intolerance to sunlight should soon have a new treatment option, following a green light for a drug from Australia’s Clinuvel Pharmaceuticals.

The biotech company is pinning its hopes on Scenesse, the first medicine for preventing phototoxicity in adults with erythropoietic protoporphyria (EPP).

After exposure to sunlight, patients with EPP feel a stinging pain in sun-exposed skin and prolonged exposure can lead to an incapacitating pain, often followed by redness and swelling.

Scenesse counters the effects of the disease, which affects fewer than 10,000 people in the European Union, by stimulating the production of a pigment called eumelanin that protects the skin.

The European Medicines Agency said its committee of experts on new drugs had decided that Scenesse should be recommended for marketing authorization under exceptional circumstances, reflecting the difficulties of conducting placebo-controlled trials.

Recommendations for marketing approval by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

(Reporting by Ben Hirschler; editing by Susan Thomas)

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EU backs drug for rare sun intolerance from Australia’s Clinuvel – Reuters

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