The US FDA approved Uplizna (inebilizumab-cdon) intravenous injection for treating patients with neuromyelitis optica spectrum disorder (NMOSD). The drug is indicated in adult patients who are having a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive).
Neuromyelitis optica spectrum disorder is an autoimmune disease that affects the optic nerve and spinal cord. The drug is the second product approved for this particular indication.
“Uplizna now represents the second approved therapy for these patients within the past year. We continue to remain highly committed to the development of additional safe and effective drugs for this rare and devastating disease,” said Billy Dunn, Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.
The approval is based on the clinical trial involving 230 adult patients with NMOSD. Two hundred thirteen patients had antibodies against AQP4. The risk of an NMOSD relapse reduced by 77% in Uplizna compared to the placebo arm in a 197-day study.
About neuromyelitis optica spectrum disorder:
In patients with neuromyelitis optica spectrum disorder, the body’s immune cells mistakenly attack the healthy cells and body proteins, especially optic nerves and spinal cord. Optic neuritis is the typical manifestation, in which patients experience pain and vision loss.
Nearly 50% of the patients with NMOSD will have visual impairment and paralysis.
The drug has prior received orphan designation.