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FDA Okays Treatment For Increasing Pain-free Light Exposure

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The U.S. Food and Drug Administration has approved Clinuvel Pharmaceuticals' treatment Scenesse for a rare genetic disorder that induces skin damage from exposure to light.

The FDA said it approved the use of Scenesse (afamelanotide) to treat erythropoietic protoporphyria or EPP, a rare genetic disorder characterized by an extreme risk of severe burns or phototoxicity of the skin on exposure to bright light, especially sunlight.

This is the first FDA-approved treatment to help EPP patients increase their light exposure.

"Today's approval is one example of the FDA's ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible," said Julie Beitz, director of FDA's Center for Drug Evaluation and Research Office of Drug Evaluation III.

EPP is a genetic disorder that causes absolute light intolerance and forces patients to lead an indoor or nocturnal existence. Exposure to light may be extremely painful for patients suffering from EPP.

Scenesse is a proprietary first-in-class photoprotective drug of Australia-based biopharmaceutical company Clinuval Pharmaceuticals. The drug treats EPP by increasing the levels of melanin in the skin and protecting against ultraviolet radiation and sunlight.

Scenesse is an implant that is administered subcutaneously, or inserted under the skin. It was approved for the prevention of phototoxicity in adult EPP patients in Europe in 2014 and launched in June 2016.

The FDA granted Priority Review designation to Scenesse's application. In addition, Scenesse received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The efficacy of Scenesse was established in two parallel group clinical trials with patients with EPP who received Scenesse or placebo form of the implant subcutaneously every two months.

The FDA cautioned that Scenesse should be administered only by a health care professional who is proficient in the subcutaneous implantation procedure and has completed the applicant-provided training.

As Scenesse may induce skin darkening, the FDA recommends a full-body skin examination for patients twice a year. Patients are also advised to maintain sun protection measures during treatment with Scenesse to prevent phototoxic reactions related to EPP.

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