Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease
Shots:
- China’s NMPA has approved Sycume for the treatment of thyroid eye disease (TED)
- Approval was based on P-III (RESTORE-1) trial in TED pts, which met its 1EP in 2024, with 85.8% pts achieving ≥2mm proptosis reduction at 24wks., along with improved inflammation & QoL; data was presented at WOC, CSE, and CCOS
- Sycume (teprotumumab N01) blocks IGF-1R signalling to reduce inflammatory factor expression & hyaluronic acid synthesis, along with other glycosaminoglycans synthesis from OFs activation. It also prevents OF differentiation into adipocytes/myofibroblasts to lower disease activity & improve symptoms such as proptosis, diplopia, orbital congestion, & edema
Ref: Prnewswire | Image: Innovent
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