The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
NMOSD is a rare autoimmune disease of the central nervous system that largely affects the optic nerves and spinal cord. The disease is often initially misdiagnosed as multiple sclerosis.
Inebilizumab is the second treatment approved for this rare autoimmune disorder. The other approved drug is eculizumab. A third drug, satralizumab, is currently under review by the FDA.
Most NMOSD patients have antibodies that bind to the AQP4 protein and the binding of the anti-AQP4 antibody can activate other components of the immune system, causing inflammation and damage to the central nervous system. Inebilizumab is a monoclonal antibody that binds to CD+19 B cells that are involved in the pathophysiology of NMOSD.
The approval was largely based on a clinical trial involving 213 adults with AQP4 antibody positive NMOSD. During the 197-day study, treatment with inebilizumab reduced NMOSD relapse by 77% compared to placebo. In the 17 patients in the study who were AQP4 antibody negative, no beneficial evidence with the drug was observed.
The prescribing information includes a warning for infusion reactions, potential depletion of certain proteins (hypogammaglobulinemia), and potential increased risk of infection – including Progressive Multifocal Leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis.
The most common adverse were urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. Women who are pregnant should not take the drug because it may cause harm to a developing fetus or newborn baby.
To learn more about NMOSD and other autoimmune conditions, visit checkrare.com/diseases/autoimmune-auto-inflammatory-disorders/