Clinuvel Pharmaceuticals Ltd. said the U.S. Food and Drug Administration verified that the target action date for its drug Scenesse is Oct. 8, not Oct. 6 as earlier announced.
Scenesse, or afamelanotide, is a potential treatment for a rare metabolic disorder known as erythropoietic protoporphyria, or EPP. The condition is characterized by photosensitivity, in which sun exposure causes itching, reddening, swelling, pain and even burns.
The regulator clarified that the previous Prescription Drug User Fee Act, or PDUFA, goal date was miscommunicated.
The original PDUFA date for the company's application was July 6. However, the FDA extended the review period in June, citing the need for more time to complete a full review of the application.
Clinuvel's chief scientific officer, Dennis Wright, said the revised PDUFA date has no material change in the company's outlook.
Scenesse received orphan-drug and fast-track status from the FDA in 2008 and 2016, respectively. The drug, which Clinuvel evaluated in five clinical trials, is approved in Europe to prevent phototoxicity in EPP patients.
