FDA Approves Inebilizumab for Neuromyelitis Optica Spectrum
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The US Food and Drug Administration (FDA) has approved inebilizumab-cdon injection (Uplizna) for the intravenous treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody.

• The indication makes ineblizumab, from Viela Bio, only the second therapy approved to treat the rare autoimmune disease of the central nervous system.

• Patients with NMOSD suffer from their body’s immune system mistakenly attacking healthy cells and protein—primarily in the optic nerves and spinal cord. As such, they’re prone to optic neuritis, which can cause eye pain and vision loss.

• Inebilizumab’s efficacy in treating NMOSD was demonstrated in a clinical assessment including 230 adult patients administered an intravenous form of the drug. Investigators noted 213 observed patients had antibodies against the AQP4 protein—which the disease binds to then activates other components of the immune system, causing inflammation and damage to the central nervous system.

• In their 197-day trial, NMOSD relapse risk was reduced by 77% in the 161 anti-AQP4 antibody positive patients treated with inebilizumab versus placebo. Investigators observed no evidence of benefit in patients who were anti-AQP4 antibody negative.

• Uplinza received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord
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