Inebilizumab

Inebilizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCD19
Names
Pronunciationin eb" i liz' ue mab
Trade namesUplizna
Other namesInebilizumab-cdon, MEDI-551
Clinical data
Main usesNeuromyelitis optica spectrum disorder (NMOSD)[1]
Side effectsUrinary tract infection, joint pain[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Intravenous
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6504H10080N1732O2044S44
Molar mass146652.90 g·mol−1

Inebilizumab, sold under the brand name Uplizna, is a medication used to treat neuromyelitis optica spectrum disorder (NMOSD) due to antibodies against aquaporin 4.[1] It is given by gradual injection into a vein.[2]

Common side effects include urinary tract infection and joint pain.[1] Other side effects may include infusion reactions and infections.[2] Use in pregnancy may harm the baby.[2] It is a monoclonal antibody that binds to CD19 on B lymphocytes and results in their breakdown.[1][2]

Inebilizumab was approved for medical use in the United States in 2020.[2] In the United States it costs about 137,000 USD per dose as of 2021.[3] It is not commercially avaliable in the United Kingdom or Europe as of 2021.[4]

Medical uses

Inebilizumab is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody (those who are anti-aquaporin-4 or AQP4 antibody positive).[5][1]

NMOSD is a rare autoimmune disorder in which immune system cells and autoantibodies attack and damage the optic nerves and spinal cord.[5] NMOSD 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.[5] 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 NMOSD a chronically debilitating and potentially life-threatening disease.[6]

Dosage

It is given at a dose of 300 mg, followed by a second dose of 300 mg after two weeks, and than 300 mg every 6 months.[1]

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.[5][1]

The most common adverse reactions in the NMOSD clinical trial were urinary tract infection, headache, joint pain (arthralgia), nausea and back pain.[5]

Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby.[5] 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.[5]

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.[5]

History

Inebilizumab was created from the research led by Thomas Tedder at Cellective Therapeutics,[7] and development was continued by Viela Bio and MedImmune.[8]

Inebilizumab was approved for medical use in the United States in June 2020.[5][9]

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.[5] In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive).[5][9] 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.[5] There was no evidence of a benefit in participants who were anti-AQP4 antibody negative.[5] 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.[9] The trial was conducted at 82 sites in 24 countries (including the United States) in North and South America, Europe, Africa, Asia and Australia.[9]

The U.S. Food and Drug Administration (FDA) granted the application for inebilizumab orphan drug designation and granted approval of Uplizna to Viela Bio.[5]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]

Society and culture

Names

Inebilizumab is the international nonproprietary name (INN) and the United States Adopted Name (USAN).[11][12]

References

  1. 1 2 3 4 5 6 7 8 9 "Uplizna- inebilizumab injection". DailyMed. 8 July 2019. Archived from the original on 13 June 2020. Retrieved 13 June 2020.
  2. 1 2 3 4 5 "Inebilizumab-cdon Monograph for Professionals". Drugs.com. Archived from the original on 6 October 2021. Retrieved 26 November 2021.
  3. ↑ "Uplizna Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 26 November 2021.
  4. ↑ "Inebilizumab". SPS - Specialist Pharmacy Service. 13 March 2018. Archived from the original on 3 October 2021. Retrieved 26 November 2021.
  5. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 "FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord". U.S. Food and Drug Administration (FDA) (Press release). 11 June 2020. Archived from the original on 18 June 2020. Retrieved 12 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ↑ "Portfolio". Viela Bio. Archived from the original on 15 November 2018. Retrieved 14 November 2018.
  7. ↑ "Uplizna launch is a 'testament' to NC's prowess in drug R&D | WRAL TechWire". 1 July 2020. Archived from the original on 8 July 2020. Retrieved 8 July 2020.
  8. ↑ "Viela Bio Spins Out of MedImmune". Viela Bio. 28 February 2018. Archived from the original on 27 June 2020. Retrieved 24 June 2020.
  9. 1 2 3 4 "Drug Trials Snapshots: Uplizna". U.S. Food and Drug Administration (FDA). 11 June 2010. Archived from the original on 2 July 2020. Retrieved 24 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ↑ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on 18 January 2021. Retrieved 17 January 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ↑ World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information. 30 (1). hdl:10665/331046. License: CC BY-NC-SA 3.0 IGO.
  12. ↑ "Inebilizumab" (PDF). USAN. Archived (PDF) from the original on 13 June 2020. Retrieved 1 July 2021.
  • Cree BA, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, et al. (October 2019). "Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial". Lancet. 394 (10206): 1352–1363. doi:10.1016/S0140-6736(19)31817-3. PMID 31495497. S2CID 201839513.
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