Innovent Reports the NMPA’s NDA Acceptance of IBI311 for Treating Thyroid Eye Disease
Shots:
- The NMPA has accepted NDA and granted priority review to the company’s IBI311 for treating Thyroid Eye Disease (TED) based on the P-III part of P-II/III (RESTORE-1) study in China
- The P-II/III (RESTORE-1; CTR20223393) study assessed the safety & efficacy of IBI311 vs PBO in Thyroid Eye Disease (TED) patients
- P-III part of RESTORE-1 study met its 1EP at wk.24, showing 85.8% vs 3.8% proptosis responder rate with a difference of 81.9% along with the 2EPs of ORR, percentage of individuals with a CAS score of 0 or 1 and mean change in proptosis from baseline. The safety profile was favorable without any SAEs and the data will be highlighted at conferences and published in journals
Ref: Innovent | Image: Innovent
Related News:- Innovent Reports Results from the P-III (RESTORE-1) Study of IBI311 for the Treatment of Thyroid Eye Disease
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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.
