Dersimelagon NDA Accepted by FDA with Priority Review for EPP, XLP

The FDA has granted Priority Review to the New Drug Application for dersimelagon, an oral treatment targeting rare genetic disorders erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), with a PDUFA date expected by February 2027. The approval would mark the first oral systemic therapy for these conditions, supported by Phase 3 clinical data from the INSPIRE study.

This Wire brief sits within Fusion42's coverage of Medtech.