www.fdanews.com/articles/197611-viela-bios-uplizna-approved-for-rare-autoimmune-disease
Viela Bio’s Uplizna Approved for Rare Autoimmune Disease
June 15, 2020
The FDA has approved Viela Bio’s Uplizna (inebilizumab-cdon) for intravenous treatment of neuromyelitis optica spectrum disorder in adults with a particular antibody.
The approval was based on the results of a clinical trial of 230 patients, in which the risk of relapse in treated patients was reduced by 77 percent compared to a placebo.
Uplizna is only the second treatment approved for the rare autoimmune disease, which affects the optic nerve and spinal cord. The FDA approved Alexion’s Soliris (eculizumab) in June 2019.