Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Humanized |
Target | CD19 |
Clinical data | |
Pronunciation |
/ɪˌnɛbɪˈlɪzjʊmæb/ i-NE-bi-LIZ-yuu-mab |
Trade names | Uplizna |
Other names | MEDI-551, inebilizumab-cdon |
AHFS/ Drugs.com | Monograph |
License data |
|
Routes of administration | Intravenous |
Drug class | Antineoplastic agent |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
|
UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6504H10080N1732O2044S44 |
Molar mass | 146652.90 g·mol−1 |
Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults. [8] [9] [5] Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells. [5]
The most common adverse reactions include urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. [8] [5]
Inebilizumab was approved for medical use in the United States in June 2020, [8] [10] in the European Union in April 2022, [7] and in Canada in December 2023. [1] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [11]
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). [8] [5]
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. [8] 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. [8] 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. [12]
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. [8] [5]
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. [8]
Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby. [8] 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. [8]
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. [8]
Inebilizumab was created from the research led by Thomas Tedder at Cellective Therapeutics, [13] and development was continued by Viela Bio and MedImmune. [14]
Inebilizumab was approved for medical use in the United States in June 2020. [8] [10]
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. [8] In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive). [8] [10] 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. [8] There was no evidence of a benefit in participants who were anti-AQP4 antibody negative. [8] 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. [10] The trial was conducted at 82 sites in 24 countries (including the United States) in North and South America, Europe, Africa, Asia and Australia. [10]
The U.S. Food and Drug Administration (FDA) granted the application for inebilizumab orphan drug designation and granted approval of Uplizna to Viela Bio. [8]
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. [15] The applicant for this medicinal product is Viela Bio. [15] Inebilizumab was approved for medical use in the European Union in April 2022. [7] [16]
Inebilizumab is the international nonproprietary name (INN) and the United States Adopted Name (USAN). [17] [18]
Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Humanized |
Target | CD19 |
Clinical data | |
Pronunciation |
/ɪˌnɛbɪˈlɪzjʊmæb/ i-NE-bi-LIZ-yuu-mab |
Trade names | Uplizna |
Other names | MEDI-551, inebilizumab-cdon |
AHFS/ Drugs.com | Monograph |
License data |
|
Routes of administration | Intravenous |
Drug class | Antineoplastic agent |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
|
UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6504H10080N1732O2044S44 |
Molar mass | 146652.90 g·mol−1 |
Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults. [8] [9] [5] Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells. [5]
The most common adverse reactions include urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. [8] [5]
Inebilizumab was approved for medical use in the United States in June 2020, [8] [10] in the European Union in April 2022, [7] and in Canada in December 2023. [1] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [11]
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). [8] [5]
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. [8] 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. [8] 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. [12]
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. [8] [5]
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. [8]
Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby. [8] 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. [8]
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. [8]
Inebilizumab was created from the research led by Thomas Tedder at Cellective Therapeutics, [13] and development was continued by Viela Bio and MedImmune. [14]
Inebilizumab was approved for medical use in the United States in June 2020. [8] [10]
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. [8] In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive). [8] [10] 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. [8] There was no evidence of a benefit in participants who were anti-AQP4 antibody negative. [8] 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. [10] The trial was conducted at 82 sites in 24 countries (including the United States) in North and South America, Europe, Africa, Asia and Australia. [10]
The U.S. Food and Drug Administration (FDA) granted the application for inebilizumab orphan drug designation and granted approval of Uplizna to Viela Bio. [8]
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. [15] The applicant for this medicinal product is Viela Bio. [15] Inebilizumab was approved for medical use in the European Union in April 2022. [7] [16]
Inebilizumab is the international nonproprietary name (INN) and the United States Adopted Name (USAN). [17] [18]