Posted by Michael Wonder on 04 Nov 2024
Ionis announces FDA acceptance of new drug application for donidalorsen for prophylactic treatment of HAE
4 November 2024 - Donidalorsen PDUFA date set for 21 August 2025.
Ionis Pharmaceuticals announced today that the US 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 paediatric patients 12 years of age and older.
