FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

Overview

• Roche’s supplemental biologics application for Enspryng (satralizumab) was accepted by the FDA on Tuesday and given Priority Review, with a target decision date of October 15, 2026.
• The filing is supported by two global, randomized, placebo‑controlled phase 3 SatraGO trials whose data were presented at ASOPRS in October 2025.
• The SatraGO studies showed clinically meaningful benefits on key signs and symptoms of thyroid eye disease, with reported secondary outcomes including clinical activity score reductions in 78–90% of active patients and diplopia improvements in 44–61% of patients.
• Enspryng is a subcutaneous IL‑6–targeting monoclonal antibody already approved for neuromyelitis optica spectrum disorder, and Roche highlights its at‑home dosing and a safety profile that differs from IGF‑1 antagonists used in TED.
• If approved, the drug would give clinicians an alternative treatment class for a progressive, potentially sight‑threatening condition and could change patient care by offering a non‑infusion, at‑home option while real‑world safety and comparative effectiveness are monitored.