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# FDA Approves Clinuvel’s Phototoxic Reactions Drug
- URL: https://www.fdaweb.com/fda-approves-clinuvels-phototoxic-reactions-drug/
- Published: 2019-10-08T12:00:00.000Z
- Updated: 2026-09-15T01:54:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145195

FDA has approved a Clinuvel NDA for Scenesse (afamelanotide) for increasing pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. Scenesse, a melanocortin-1 receptor agonist that is administered subcutaneously, increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources, an [FDA notice](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder?ref=fdaweb.com) says.  

Approval was based on data from two parallel group clinical trials in patients with erythropoietic protoporphyria who received Scenesse or a placebo subcutaneously every two months. “The median total number of hours over 180 days spent in direct sunlight between 10 am and 6 pm on days with no pain was 64 hours for patients receiving Scenesse and 41 hours for patients taking placebo,” FDA says.