SCENESSE has been developed for the treatment of erythropoietic protoporphyria (EPP), a rare genetic enzymatic disorder causing lifelong absolute light intolerance.
Clinuvel will submit the modular dossier on SCENESSE on a rolling basis during the first half of 2017.
After the completion of the submission of the dossier, the FDA will observe a validation period of two months.
Notably, a positive benefit-risk assessment of SCENESSE by the FDA is expected to make the drug available as the first systemic photoprotectant for adult EPP patients.
Photoprotection is a group of mechanisms that help living organisms cope with molecular damage caused by sunlight.
The pharmaceutical product is currently being prescribed in specialist centres for treatment of EPP patients within the European Union.
In July the FDA granted SCENESSE a Fast Track Designation for the treatment of EPP, enabling CLINUVEL to file an NDA on a rolling basis.
The company also received an invitation to attend a Type B pre-NDA meeting in October.
Clinuvel is well funded with $17 million in cash as at 30 September 2016.