The Australian Therapeutic Goods Administration (TGA) has enabled Priority Registration Pathway for SCENESSE® for the treatment of Erythropoietic Protoporphyria (EPP). This review pathway gives a target time frame of 150 working days from submission of the a new drug application.
The APF congratulates the Australian EPP community on this progress! SCENESSE® was approved by the US Food and Drug Administration on October 8, 2019. Distribution and reimbursement arrangements are in preparation.