Intravenous inebilizumab (Uplizna) won approval to treat neuromyelitis optica spectrum disorder (NMOSD), the FDA announced late Thursday.
The anti-CD19, B-cell depleting monoclonal antibody was approved to treat adult NMOSD patients positive for anti-aquaporin-4 (AQP4) antibodies. NMOSD is a rare, severe, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, and brain stem.
Inebilizumab is the second treatment approved for NMOSD. The first was eculizumab (Soliris), approved in 2019.
