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Inebilizumab
Monoclonal antibody From Wikipedia, the free encyclopedia
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Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults[9][10][6] and IgG4-RD.[11] Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells.[6]
The most common adverse reactions include urinary tract infection, headache, joint pain (arthralgia), nausea and back pain.[9][6]
Inebilizumab was approved for medical use in the United States in June 2020,[9][12] in the European Union in April 2022,[8] and in Canada in December 2023.[2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13]
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Medical uses
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Perspective
Inebilizumab is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive).[9][6]
Neuromyelitis optica spectrum disorder is a rare autoimmune disorder in which immune system cells and autoantibodies attack and damage the optic nerves and spinal cord.[9] Neuromyelitis optica spectrum disorder can be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system.[9] Clinically, the disease is manifested with attacks/relapses that result in neurological impairment such as blindness, paraplegia, sensory loss, bladder dysfunction, and peripheral pain. The disability from each attack is cumulative, making neuromyelitis optica spectrum disorder a chronically debilitating and potentially life-threatening disease.[14]
In April, 2025 the FDA approved the Uplizna as the first treatment for adults living with immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can affect multiple organs.[11]
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Side effects
The label for inebilizumab 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.[9][6]
The most common adverse reactions in the neuromyelitis optica spectrum disorder clinical trial were urinary tract infection, headache, joint pain (arthralgia), nausea and back pain.[9]
Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby.[9] The FDA advises health care professionals to inform females of reproductive age to use effective contraception during treatment with inebilizumab and for six months after the last dose.[9]
Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks prior to initiation of inebilizumab.[9]
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History
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Inebilizumab was created from the research led by Thomas Tedder at Cellective Therapeutics,[15] and development was continued by Viela Bio and MedImmune.[16]
Inebilizumab was approved for medical use in the United States in June 2020.[9][12]
The effectiveness of inebilizumab for the treatment of NMOSD was demonstrated in a clinical study (NCT02200770) of 230 adult participants that evaluated the efficacy and safety of intravenous inebilizumab.[9] In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive).[9][12] During the 197-day study, the risk of an NMOSD relapse in the 161 anti-AQP4 antibody positive participants who were treated with inebilizumab was reduced by 77% when compared to the placebo treatment group.[9] There was no evidence of a benefit in participants who were anti-AQP4 antibody negative.[9] The primary efficacy endpoint was the time to the onset of the first adjudicated relapse on or before study day 197 evaluated by a blinded, independent, adjudication committee, who determined whether the attack met protocol-defined criteria.[12] The trial was conducted at 82 sites in 24 countries (including the United States) in North and South America, Europe, Africa, Asia and Australia.[12]
The U.S. Food and Drug Administration (FDA) granted the application for inebilizumab orphan drug designation and granted approval of Uplizna to Viela Bio.[9]
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Legal status
In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Uplizna, intended for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive.[17] The applicant for this medicinal product is Viela Bio.[17] Inebilizumab was approved for medical use in the European Union in April 2022.[8][18]
Names
Inebilizumab is the international nonproprietary name (INN) and the United States Adopted Name (USAN).[19][20]
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References
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External links
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