Home » Roche’s Neuromyelitis Optica Drug Enspryng Wins EU Approval
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.
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