Shots:
- The US FDA has accepted sBLA & granted priority review to Roche‘s Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026
- sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev. TED & chronic inactive TED
- Trials showed clinically meaningful TED improvements, with SatraGO-2 meeting the 1EP of proptosis response at Wk. 24 (53% vs 23%), while SatraGO-1 showed a numerical benefit (49% vs 31%). Enspryng improved CAS in 78% to 90% & diplopia in 44% to 61% pts with active TED across SatraGO-1 & 2, respectively
Ref: Globenewswire | Image: Roche |Press Release
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