MeiraGTx granted FDA RMAT designation for AAV2-hAQP1 in Grade 2/3 radiation-induced xerostomia

MeiraGTx Holdings plc

FDA's RMAT designation includes Fast Track, Breakthrough Therapy benefits and potential Priority Review and accelerated approval.
Phase 1 AQUAx trial showed significant patient-reported outcomes and saliva production improvements with no serious adverse events.
Phase 2 AQUAx2 double-blind, placebo-controlled trial is enrolling; FDA agreed Phase 2 may serve as pivotal trial for BLA filing.
AAV2-hAQP1 previously received FDA Orphan Drug Designation for this indication.

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