The FDA approved afamelanotide (Scenesse) for the treatment of adult patients with a history of phototoxic reactions caused by erythropoietic protoporphyria. It is the first medication approved for this condition.
Afamelanotide, a melanocortin-1 receptor agonist, is a subcutaneously administered implant designed to increase pain-free light exposure by increasing the production of eumelanin in skin independent of sunlight or artificial light exposure.
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Data from 2 parallel group clinical trials supported the efficacy of afamelanotide for increasing pain-free sun exposure compared with placebo.
The most common adverse events included implant site reactions, nausea, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria, and skin irritation. A full body examination is recommended twice a year for patients treated with afamelanotide in addition to sun protection.
FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder [press release]. Silver Spring, MD: FDA; October 8, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder. Accessed October 8, 2019.