Also known as Enspryng.
Phase III fenebrutinib data show reduced chronic active MS lesions and a 55% ARR cut; Ocrevus shows durable pediatric and older-adult control; Enspryng supports MOGAD attack reduction.
A first‑in‑class IL‑6R inhibitor and the first and only at‑home subcutaneous treatment option for thyroid eye disease.
FDA clears the first at‑home subcutaneous IL‑6R treatment for TED; Phase III SatraGO‑2 showed marked proptosis and diplopia improvements and safety consistent with prior NMOSD data.
FDA accepted the application for satralizumab for adult and adolescent MOGAD and granted Priority Review with a decision due 10 Jan 2027; EMA validated the MAA, EC decision expected Q3 2027.
FDA to decide by 10 Jan 2027 on satralizumab for MOGAD after Phase III METEOROID showed 68% relapse risk reduction; EMA validation pending EC decision in Q3 2027.
Priority Review follows Phase III METEOROID showing 68% relapse risk reduction; FDA decision expected Jan 10, 2027; EMA validated the MOGAD filing with EC decision due Q3 2027.
Regulatory submission seeks approval of satralizumab to prevent relapse in MOG antibody‑associated disease after Phase III showed a 68% risk reduction.
FDA accepted an sBLA and granted Priority Review for the first at‑home subcutaneous option for thyroid eye disease; decision expected 15 Oct 2026.
