2019 Announcements

US FDA extends PDUFA date for SCENESSE®

Melbourne, Australia 3 June 2019

Download PDF

The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision


Executive summary

  • New PDUFA goal date set for 6 October 2019
  • New timeline to communicate labelling changes and post-marketing commitments by 6 September 2019
  • Scientific exchange between FDA and CLINUVEL continues under Priority Review
  • The FDA is not intending to hold advisory committee meeting
  • New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act.

CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a new Prescription Drug User Fee Act (PDUFA) goal date of 6 October 2019 to provide it with more time for a full review of the submission of the SCENESSE® (afamelanotide 16mg) scientific dossier.

CLINUVEL submitted a New Drug Application (NDA) – under Section 505(b) of Federal Food, Drug, and Cosmetic Act – for the use of SCENESSE® in the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP) in 2018.


The FDA communicated on 31 May 2019 after market close that it has set a new goal date of 6 October 2019 to allow time to evaluate data provided by CLINUVEL as part of the scientific exchange within the review process. A new timeline for communicating labelling changes and/or post-marketing requirements and commitments by 6 September 2019 was also communicated.

Following an assessment under 21 CRF 314.101(a) for NDA completeness, the FDA review then assesses the risk-benefit profile of the product for the intended patient population. The scientific exchange between the FDA and CLINUVEL under Priority Review continues during these final stages of the review process. The FDA has previously advised that it does not intend to hold an advisory committee meeting during the scientific review of the SCENESSE® NDA.


“The US FDA has the ability to extend review dates when the review process requires more time than it had anticipated,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “It is disappointing for the US EPP patients that they will have to wait further for the treatment to be available, and we will continue to work around the clock to assist the FDA staff to reach a positive conclusion on the scientific review of SCENESSE®. We recognise the finite resources the US FDA currently has and will patiently wait for the communication on labelling and post-marketing commitments by 6 September.”


SCENESSE® is a controlled release injectable implant containing the novel active ingredient afamelanotide. The drug was developed as a first-line treatment for patients with EPP, a rare genetic metabolic disorder which causes phototoxicity and anaphylactoid reactions when patients expose their skin to light. CLINUVEL conducted five clinical trials of SCENESSE® in EPP. Two randomised, placebo-controlled clinical trials of SCENESSE® conducted at US EPP expert centres showed the drug enabled patients to increase the amount of time spent outside without experiencing phototoxicity and improved patient quality of life.

SCENESSE® was granted orphan drug designation by the FDA in 2008. In July 2016 the FDA, having assessed the clinical data package for the main EPP studies, advised that the data were ready for NDA submission, and in November 2016 a pre-NDA meeting was held. In October 2016, the FDA organised a first Scientific Workshop on EPP as part of a pilot scheme to involve patients and their families in the scientific review of disease and treatment solutions. On 22 June 2018 CLINUVEL filed the final module of the NDA for SCENESSE® under “rolling review”. Additional data were submitted in response to questions from the FDA during the preliminary review period.

SCENESSE® was approved for the prevention of phototoxicity in adult patients with EPP in Europe in 2014.1 CLINUVEL seeks US regulatory approval for the same treatment dose and regimen in the United States as is currently approved in the European Union, where SCENESSE® is prescribed to EPP patients by clinical experts at specialised treatment centres. There are currently no approved therapies for EPP patients in the US.

– End –

1SCENESSE® (afamelanotide 16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP. Information on the product can be found on CLINUVEL’s website at www.clinuvel.com.

Go To Top