Ionis Reports the US FDA’s NDA Acceptance of Donidalorsen as a Prophylactic Treatment of Hereditary Angioedema (HAE)
Shots:
- The US FDA has accepted the NDA of donidalorsen (RNA product targeting prekallikrein) as a prophylactic treatment against attacks in patients (≥12yrs.) with hereditary angioedema, with the decision expected on Aug 21, 2025
- NDA filing was based on P-III (OASIS-HAE & OASISplus) trials & an ongoing P-II OLE trial, depicting a 96% overall mean reduction in HAE attacks that sustained for 3yrs. with well-tolerated safety and no serious TEAEs; AEs included mild or moderate injection site reactions. Data was highlighted at ACAAI 2024
- Additionally, Otsuka holds exclusive commercialization rights across the EU & Asia Pacific plus anticipates MAA filing with the EMA in Q4’24
Ref: Ionis | Image: Ionis
Related News:- Ionis Reports Data from the P-III (OASIS-HAE) Trial of Donidalorsen for the Treatment of Hereditary Angioedema
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
