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# FDA Accepts Clinuvel NDA for Skin Exposure Drug
- URL: https://www.fdaweb.com/fda-accepts-clinuvel-nda-for-skin-exposure-drug/
- Published: 2019-01-10T12:00:00.000Z
- Updated: 2026-09-15T00:53:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143129

FDA has accepted for review a Clinuvel Pharmaceuticals 505(b)(2) NDA for Scenesse (afamelanotide) 16mg for preventing phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria whose skin is exposed to light. Scenesse was granted orphan drug designation by FDA in 2008, and it was approved for use in Europe in 2014.The agency has set a review action target date of 7/8.

The submission is based on data from five clinical trials. Two randomized, placebo-controlled clinical trials showed that the drug enabled patients to increase the amount of time spent outside without experiencing phototoxicity and improving patient quality of life, the company says. FDA has told Clinuvel that it does not intend to hold an advisory committee meeting during the final review of the submission.