CHMP recommends approval of Enspryng for neuromyelitis optica spectrum disorder.- Roche

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (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 (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course.The CHMP recommendation is based on the results of the Phase III SAkuraStar and SAkuraSky studies in which Enspryng showed robust and sustained efficacy results in reducing the risk of relapse and a favourable safety profile in people with AQP4-IgG seropositive NMOSD. A final decision regarding the approval is expected from the European Commission in the near future.