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Scenesse FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 6, 2019.

FDA Approved: Yes (First approved October 8, 2019)
Brand name: Scenesse
Generic name: afamelanotide
Dosage form: Implant
Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Prevention of Phototoxicity in Erythropoietic Protoporphyria

Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

  • Scenesse is a subcutaneous implant administered every two months by a healthcare professional proficient in the subcutaneous implantation procedure.
  • Patients should maintain sun protection measures during treatment with Scenesse to prevent phototoxic reactions related to erythropoietic protoporphyria.
  • Scenesse may induce skin darkening, and a full body skin examination is recommended twice a year.
  • Patients should monitor the implant insertion site and report any reactions to their healthcare provider.
  • Common side effects include implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation.

Development timeline for Scenesse

Oct  8, 2019Approval FDA Approves Scenesse (afamelanotide) for Prevention of Phototoxicity in Erythropoietic Protoporphyria
Jun  3, 2019US FDA Review for Scenesse Extended 3 Months
Jun 25, 2018Clinuvel Completes Scenesse FDA Filing
Jun 25, 2018Historic New Drug Application for the use of Scenesse (afamelanotide) in Rare Metabolic Disorder Erythropoietic Protoporphyria (EPP)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.