Arrowhead Pharmaceuticals (ARWR) said Monday a phase 3 study of investigational plozasiran in patients with familial chylomicronemia syndrome met its primary endpoint and all multiplicity-controlled key secondary endpoints.
Familial chylomicronemia syndrome is a genetic disease often caused by monogenic mutations, leading to very high triglyceride levels and causing various serious symptoms.
Plozasiran reduced triglycerides by 80% from baseline and lowered the risk of developing acute pancreatitis by 83%, the company said.
Arrowhead plans to file a new drug application with the US Food and Drug Administration by the end of 2024 and also seek regulatory approval from other authorities thereafter.
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