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Clinuvel Pharmaceuticals receives FDA approval for SCENESSE

The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price will be one to watch this week after the U.S. Food and Drug Administration (FDA) finally approved its treatment for erythropoietic protoporphyria (EPP), a rare inherited disorder that results in skin damage from exposure to light.

SCENESSE has been developed as a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder. It has been approved for sale in Europe for several years and has been generating strong revenues for the company. So, the decision by the FDA is expected to give its sales a major boost.

Especially given that it had no approved treatment in the United States, until now. Previously EPP sufferers in the United States were forced to cover up their skin or even stay inside during the day and live their lives by night. SCENESSE can help sufferers go outside without experiencing painful reactions to the sunlight.

What did the FDA say?

Julie Beitz, M.D., director of FDA’s Center for Drug Evaluation and Research Office of Drug Evaluation, said: “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.”

She advised that: “Scenesse should be administered by a health care professional who is proficient in the subcutaneous implantation procedure and has completed the applicant-provided training. Scenesse may induce skin darkening, and a full body skin examination is recommended for patients twice a year. In addition, patients are encouraged to maintain sun protection measures during treatment with Scenesse to prevent phototoxic reactions related to erythropoietic protoporphyria.”

What now?

As this news broke during the night, Clinuvel has yet to provide an update with its take on the positive development. But rest assured, there will be more on that when its announcement is made and its shares return from their trading halt. Yesterday management requested the halt until Friday as it prepares its response to the FDA’s decision.

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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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