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Media Release – US FDA review for SCENESSE® extended 3 months

Melbourne, Australia 3 June 2019

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

CLINUVEL PHARMACEUTICALS LTD today published that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products (DDDP) has set a new Prescription Drug User Fee Act (PDUFA) goal date of 6 October 2019 for CLINUVEL’s drug SCENESSE® (afamelanotide 16mg). The FDA also revised the expected date to provide commentary on product labelling and CLINUVEL’s post-marketing authorisation commitments to 6 September. From the FDA’s communication it is understood that the DDDP requires more time to complete a full review of the submission of the SCENESSE® new drug application (NDA) scientific dossier.

CLINUVEL submitted an 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.

CHRONOLOGY

SCENESSE® was granted an orphan drug designation by the FDA in 2008. In March 2016, CLINUVEL was asked by the DDDP to submit its clinical data. In October 2016, the FDA held its first public workshop on EPP inviting 150 patients and their families to learn more about the restrictions and impact of the disorder. In July 2016 the FDA determined that the NDA filing met the Fast Track Designation criteria, enabling a regulatory review on a rolling basis. In November 2016, the FDA invited CLINUVEL for a pre-NDA meeting, and it was deemed that the Company was ready to file its scientific dossier on SCENESSE®.

The submission under rolling review started in 2018. In January 2019 the FDA validated the NDA filing and awarded the product Priority Review, providing for a scientific review of six months with an initial PDUFA user fee goal date of 8 July. The FDA had previously advised that it does not intend to hold an advisory committee meeting during the scientific review of the SCENESSE® NDA.

On 31 May, the DDDP extended its own timeline – determined under Priority Review – allowing for more review time with a new PDUFA user fee goal date set to 6 October 2019.

Following an assessment under 21 CRF 314.101(a) for NDA completeness, the FDA review will assess the risk-benefit profile of the product for the intended patient population. The exchange between the FDA and CLINUVEL continues during these final stages of the scientific review process.

COMMENTARY

“It is not unusual to see the FDA extend its own timelines when it finds that it requires more time for review and to arrive at a final benefit-risk assessment,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.

“It is most frustrating that, while SCENESSE® is being prescribed in the European Union and Switzerland and some of the US patients travel to Europe to obtain the treatment, the majority of US EPP patients have no access.

“We will continue to work with the FDA to work at all possible hours to assist the FDA staff to reach a positive conclusion on the scientific review of SCENESSE®. We are sympathetic to the finite resources the US FDA currently has and will patiently wait for the communication on labelling and post-marketing commitments by 6 September,” Dr Wright concluded.

SCENESSE® FOR EPP

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 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.