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Scenesse Approval History

Reviewed by J.Stewart BPharm Last updated on Oct 14, 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 History and FDA Approval Process 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)
Dec 19, 2012Scenesse Successful in Phase IIa Vitiligo Study
Dec 20, 2011Clinuvel announces positive results from pivotal European Phase III study: endpoints demonstrate clinically relevant treatment effect of afamelanotide
Nov  3, 2011Clinuvel announces positive results of first Phase II US study of SCENESSE┬« in orphan disease erythropoietic protoporphyria (EPP)
Jul 13, 2010Clinuvel Pharmaceuticals Limited (ASX:CUV) Successful Drug Trial Results For Light Intolerant Shadow Jumpers
Dec 18, 2009Clinuvel announces PLE Phase III preliminary results
Dec  9, 2009Drug improves quality of life in cancer patients, Clinuvel strengthens filing dossier
Jan 21, 2009Clinuvel: Positive Interim Phase III Results Announced for Unique Skin Protection Drug

Further information

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