CHGCF - European advisory group backs approval Roche's Enspryng for NMOSD

The EMA's Committee for Medicinal Products for Human Use ((CHMP)) has recommended the approval of Roche (RHHBY) unit Chugai Pharmaceutical's (CHGCF) Enspryng (satralizumab), as the treatment for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder ((NMOSD)), as a monotherapy or in combination with immunosuppressive therapy ((IST)). The positive recommendation is based on the results from two global phase III clinical studies in people with NMOSD: SAkuraSky Study and SAkuraStar Study.SAkuraSky evaluated Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar assessed monotherapy. NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and causes a continual and significant decrease in quality of life due to permanent neurological disability.

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European advisory group backs approval Roche's Enspryng for NMOSD