Industry/Regulatory Developments
The approved afamelanotide product is a 16 mg implant called Scenesse
FDA approved Scenesse in 2019 for adults with erythropoietic protoporphyria. The label describes an implant given every two months, not a tanning vial.
Afamelanotide reached a United States label. Scenesse is a melanocortin-1 receptor agonist indicated to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. The 2019 prescribing information describes a 16 mg implant, placed subcutaneously by a trained professional, every two months. Initial approval was 2019.
The label moved after approval
A 2024 revision of the same application changed parts of the dosage, contraindications, and warnings, including language on serious hypersensitivity. That is what a label does after approval: it is revised by supplement. A forum summary of the 2019 PDF can be out of date. The current FDA record is the one to trust when the two PDFs disagree.
What the label does not cover
Melanotan II is not named as Scenesse. A research vial is not the bioresorbable implant. The trial paper (PMID 26132941) is the evidence summary behind the indication; the label is the regulatory document that states the indication, the implant, and the warnings. They are read together, and neither one is a catalog page.