Arrowhead Receives FDA Fast Track Designation for ARO-APOC3
ARO-APOC3 is Arrowhead’s investigational RNAi therapeutic targeting apolipoprotein C-III (APOC3) being developed as a treatment for patients with severe hypertriglyceridemia (SHTG), mixed dyslipidemia (MD), and
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. The purpose is to get important new drugs to patients earlier. This designation makes Arrowhead eligible for multiple potential benefits including more frequent interactions with FDA, eligibility for accelerated approval and priority review, and rolling review of the new drug application (NDA).
ARO-APOC3 is being investigated in the Phase 3 PALISADE clinical study (NCT05089084) in patients with
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