Posted by Michael Wonder on 24 Apr 2021
CHMP recommends EU approval of Roche’s Enspryng (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder
23 April 2021 - Recommendation is based on results from the two pivotal Phase 3 SAkuraStar and SAkuraSky trials, in which Enspryng demonstrated robust and sustained efficacy in reducing the risk of relapse and a favourable safety profile.
Roche announced today that the EMA's CHMP has recommended the approval of Enspryng (satralizumab) as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder, as a monotherapy or in combination with immunosuppressive therapy
