Arrowhead granted Fast Track designation for ARO-APOC3 by FDA

Arrowhead announced the FDA has granted Fast Track designation to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome, or FCS. ARO-APOC3 was previously granted Orphan Drug designation by the FDA and the European Union. ARO-APOC3 is Arrowhead’s investigational RNAi therapeutic targeting apolipoprotein C-III, or APOC3, being developed as a treatment for patients with severe hypertriglyceridemia, or SHTG, mixed dyslipidemia, or MD, and FCS. FCS is a rare genetic disorder that causes severely elevated triglyceride levels, which can result in acute and potentially fatal pancreatitis. There are currently no FDA approved therapies to treat FCS.