SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has accepted the company's Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder or NMOSD.
The European Medicines Agency (EMA) has also validated the company's Marketing Authorization Application (MAA) for satralizumab, granting it Accelerated Assessment. The FDA decision and the EMA's Committee for Medicinal Products for Human Use (CHMP) recommendation are expected in 2020.
Neuromyelitis optica spectrum disorder is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis.
People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability. In some cases, relapse can result in death.
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