Roche’s Neuromyelitis Optica Drug Enspryng Wins EU Approval
Roche has secured European Commission approval for Enspryng (satralizumab) for treating adolescents and adults with neuromyelitis optica spectrum disorder (NMOSD), a central nervous system condition that can cause blindness, paralysis and painful spasms.
The drug, which the commission authorized as either a monotherapy or combined with immunosuppressive therapy, is administered subcutaneously every four weeks.
The approval was supported by two phase 3 studies which showed the drug offered “robust and sustained efficacy” in reducing the risk of disease relapse. Enspryng works by binding and blocking the interleukin-6 receptor that causes inflammation linked with NMOSD.
The treatment received FDA approval for the same indication in August.