ARWR - Arrowhead wins FDA Fast Track status for lipid lowering agent

2023-03-20 08:23:13 ET

• Arrowhead Pharmaceuticals ( NASDAQ: ARWR ) added ~7% in the pre-market Monday after announcing that the FDA issued Fast Track designation for its RNAi therapeutic ARO-APOC3 for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS).
• A rare genetic disorder with no FDA-approved therapies, FCS is characterized by sharply increased triglyceride levels that can lead to acute and sometimes even life-threatening cases of pancreatitis.
• The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
• If certain criteria are met, such programs will also be able to win Accelerated Approval and Priority Review, enabling patients to access those treatments sooner.
• Designed to target apolipoprotein C-III (APOC3), ARO-APOC3 is an experimental therapy studied for severe hypertriglyceridemia and mixed dyslipidemia in addition to FCS.
• In 2019, the FDA granted Orphan Drug designation for ARO-APOC3 as a treatment for FCS.

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