Ionis Pharmaceuticals (IONS) announced that the U.S. FDA has accepted for review the New Drug Application for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older. The FDA has set an action date of August 21, 2025 under the Prescription Drug User Fee Act. The FDA application was based on positive results with monthly and bi-monthly dosing in the pivotal Phase 3 OASIS-HAE and OASISplus studies, as well as the ongoing Phase 2 OLE study.
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