Posted by Michael Wonder on 04 Jun 2019
US FDA review for Scenesse extended by three months
3 June 2019 - The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision.
Clinuvel Pharmaceuticals today published that the US FDA Division of Dermatology and Dental Products (DDDP) has set a new Prescription Drug User Fee Act goal date of 6 October 2019 for Clinuvel’s drug Scenesse (afamelanotide 16 mg). 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 scientific dossier.
Clinuvel submitted an application – 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 in 2018.
