The FDA has announced approval of Soliris injection for treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive.
The approval was granted to Alexion Pharmaceuticals and is the first for treatment of the rare autoimmune disease.
According to an FDA news release, a study of 143 patients randomized to receive intravenous Soliris (eculizumab) or placebo showed that treatment with the study drug reduced neuromyelitis optica spectrum disorder (NMOSD) relapses by 94% over 48 weeks. Soliris treatment also resulted in fewer hospitalizations and
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