Ionis Reports Data from the P-III (OASIS-HAE) Trial of Donidalorsen for the Treatment of Hereditary Angioedema
Shots:
- The company has reported results from the P-III (OASIS-HAE) trial evaluating donidalorsen (80mg, SC, Q4W & Q8W for 24wks.) vs PBO in patients (n=91) aged 12yrs. and above, randomized to 2:1, with type 1 and type 2 hereditary angioedema (HAE)
- The study met 1EP of reduction in the rate of angioedema attacks, 2EPs in both Q4W and Q8W groups and showed a favorable safety and tolerability profile without any SAEs. Ionis anticipates NDA filing with the US FDA based on these results
- Additionally, Otsuka holds exclusive commercialization rights across the EU and anticipates MAA filing with the EMA. Moreover, the drug has received ODD by the US FDA while the ODD procedure is underway in the EU
Ref: Ionis | Image: Ionis
Related News:- Ionis and Otsuka Sign License Agreement to Develop and Commercialize Donidalorsen for Hereditary Angioedema (HAE) in Europe
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
