FDA approves Uplizna for neuromyelitis optica spectrum disorder
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Viela Bio has received FDA approval for Uplizna, an intravenous treatment for neuromyelitis optica spectrum disorder in certain adults.
The treatment, inebilizumab-cdon injection, is the second approved therapy for neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (anti-AQP4) antibody positive. The first was Soliris (eculizumab, Alexion Pharmaceuticals), which was approved in June 2019.
“We continue to remain highly committed to the development of additional safe and effective drugs for this rare and devastating disease,” Billy Dunn, MD, director of the Office of Neuroscience, FDA Center for Drug Evaluation and Research, said in a press release.
Uplizna had received orphan drug designation to be studied for NMOSD, which affects the optic nerve and the spinal cord. NMOSD can cause optic neuritis, leading to eye pain and vision loss.
In a clinical trial of 230 patients, inebilizumab-cdon demonstrated a 77% reduced risk for relapse in anti-AQP4 antibody positive patients vs. those given placebo. No benefit was seen in patients who were anti-AQP4 antibody negative.
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