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FDA and EMA agree to review Roche’s satralizumab applications

November 01, 2019 / Pharmaceutical Technology

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted Roche’s applications for its investigational drug satralizumab in neuromyelitis optica spectrum disorder (NMOSD). Roche is seeking approval for the drug to treat adult and adolescent patients. EMA granted accelerated assessment to the application. In December last year, the FDA awarded breakthrough therapy status to satralizumab for NMOSD. The company expects to receive the FDA decision and recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP) in 2020. NMOSD is a rare, autoimmune condition affecting the central nervous system. The disorder causes damage to the optic nerve(s) and spinal cord, which lead to blindness, muscle weakness and paralysis. Satralizumab is a humanised monoclonal antibody designed to target the receptor of the cytokine IL-6, which is believed to drive NMOSD by inducing the inflammation cascade and causing damage and disability. Roch...