Logo

Ionis Reports Data from the P-III (OASIS-HAE) Trial of Donidalorsen for the Treatment of Hereditary Angioedema

Share this
Ionis

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

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

 

Click here to­ read the full press release 

Shivani Chandra

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.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions