Pharmaceutical company Roche has received accelerated approval review from the US Food and Drug Administration (FDA) for Enspryng, a treatment for the rare autoimmune disorder MOGAD. In MOGAD, the immune system mistakenly attacks the central nervous system, leading to vision loss, paralysis, and other neurological damages. Currently, there are no approved treatments for this condition, as stated in a Thursday announcement.
The approval is based on the Phase-III Meteoroid study, which showed that Enspryng reduced the relapse risk in MOGAD patients by 68% compared to placebo. After 48 weeks, 87% of patients treated with Enspryng were relapse-free, compared to 67% in the placebo group. The study was presented at the American Academy of Neurology's annual congress in April 2026.
The FDA will decide on the approval by January 10, 2027. The European Medicines Agency (EMA) is also reviewing the application, with an expected decision from the European Commission in the third quarter of 2027.
Enspryng is already approved in around 90 countries, including the USA and the EU, for the treatment of a related nervous system disorder called Neuromyelitis-optica-Spectrum Disorder. The medication was developed by Chugai, a company within the Roche group.
