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FDA Grants Priority Review for Satralizumab in MOGAD
Overview
The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application for the interleukin-6 (IL-6) inhibitor satralizumab (Enspryng; Genentech/Roche) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Satralizumab is currently approved for treating aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD) and previously received priority review in June for the treatment of thyroid eye disease.
Siรขn Lennon-Chrimes, PhD, global development leader of neuroimmunology at Roche Pharma Development, highlighted the clinical significance of this regulatory milestone for patients:
โMyelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a rare autoimmune disease that can attack the optic nerves, brain and spinal cord and cause severe and unpredictable relapses, resulting in accumulating neurological damage, vision loss and disabilityโ. โCurrently, there are no approved treatment options for this debilitating diseaseโ. โIf approved, Enspryng would address a critical treatment gap as the first and only disease-modifying therapy for people living with MOGADโ.
Clinical Trial Efficacy and Safety
The supplemental application is supported by findings from the phase 3 METEOROID study, which demonstrated that satralizumab provided โconsistent, clinically meaningful improvementsโ for patients with MOGAD.
The trial successfully met its primary endpointโevaluating the time to the first MOGAD relapse during the treatment period. Furthermore, treatment with satralizumab yielded โsignificant improvements across key secondary measures, including annualized relapse rate, MRI lesion activity and rescue therapy useโ. In terms of safety, the outcomes were consistent with prior trials investigating satralizumab in patients with NMOSD.
Table 1. Phase 3 METEOROID Study Efficacy Outcomes
| Efficacy Measure | Trial Findings |
| Primary Endpoint (Risk of Relapse) | Satralizumab reduced the risk for a relapse by 68% compared with placebo (P = .0025). |
| Relapse-Free Rate at 48 Weeks (Satralizumab) | 87% of patients treated with satralizumab remained relapse-free. |
| Relapse-Free Rate at 48 Weeks (Placebo) | 67% of patients who received the placebo remained relapse-free. |
Reflecting on these clinical outcomes, Lennon-Chrimes added:
โThe study also showed that Enspryng has the potential to reduce central nervous system inflammation and the need for rescue therapiesโ. โEnspryng is the first medicine to show a meaningful clinical benefit for people with MOGAD in a pivotal trialโ. โIt is the only positive pivotal study in MOGAD, addressing the underlying neurological disability experienced by this patient populationโ.
Regulatory Timelines
The FDA is expected to issue a final decision regarding the approval of satralizumab for MOGAD by January 10, 2027. Additionally, the European Commission is anticipated to render a decision on the therapy in the third quarter of 2027.
