FDA grants priority review to satralizumab as first potential therapy for rare CNS disease
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The FDA has granted priority review to the registration application for satralizumab (Enspryng) in MOGAD (search), an autoimmune disease attacking the myelin sheath (search) of nerve fibres.
The filing rests on Phase III data showing a 68% reduction in relapse risk versus placebo, with 87% of treated patients relapse-free at 48 weeks.
The EMA has validated the European marketing authorisation application for the same indication, with an FDA decision expected by 10 January 2027.
The FDA has granted priority review to the registration application for satralizumab (Enspryng) in MOGAD (search), a rare autoimmune disease of the central nervous system in which the immune system attacks the myelin sheath (search) of nerve fibres. The drug is expected to become the first and so far only disease-modifying therapy for the condition. Satralizumab has been approved in the US since 2020 for neuromyelitis optica (search), and has been used for that indication in Russia since 2021.
The priority review is based on Phase III results in which satralizumab reduced the risk of a new relapse by 68% compared with placebo. After 48 weeks, 87% of patients receiving satralizumab remained relapse-free versus 67% in the placebo group. This is the second FDA priority review decision for satralizumab, following a similar decision for thyroid eye disease (search) in June 2026. The agency is expected to decide by 10 January 2027.
The EMA has also validated the marketing authorisation application for satralizumab in MOGAD (search), with a European Commission decision expected in the third quarter of 2027. MOGAD affects men and women in roughly equal numbers and is often seen in children, whereas neuromyelitis optica (search) more often debuts in adulthood, with 80 to 90% of cases occurring in women.
Source: gxpnews.net