Arrowhead (ARWR) Pharmaceuticals announced that the U.S. FDA has accepted the New Drug Application for investigational plozasiran for the treatment of familial chylomicronemia syndrome, a severe and rare genetic disease. The FDA provided a Prescription Drug User Fee Act action date of November 18, and indicated it is not currently planning to hold an advisory committee meeting. Arrowhead also intends to submit applications for approval of investigational plozasiran for the treatment of patients with FCS to additional regulatory authorities in 2025.
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