Omalizumab structure: (A) murine complementarity-determining region and (B) IgG1κ human framework
Monoclonal antibody
Type
Whole antibody
Source
Humanized (from mouse)
Target
IgE Fc region
Clinical data
Pronunciation
/ˌoʊməˈlɪzumæb/ OH-mə-LI-zoo-mab
Trade names
Xolair
AHFS/Drugs.com
Monograph
MedlinePlus
a603031
License data
US DailyMed: Omalizumab
Pregnancy category
AU: B1
Routes of administration
Subcutaneous
ATC code
R03DX05 (WHO)
Legal status
Legal status
AU: S4 (Prescription only)[2][3]
CA: ℞-only / Schedule D[4][5][6]
UK: POM (Prescription only)[7]
US: WARNING[1]Rx-only[8]
EU: Rx-only[9]
Pharmacokinetic data
Elimination half-life
26 days
Identifiers
CAS Number
242138-07-4Y
DrugBank
DB00043Y
ChemSpider
none
UNII
2P471X1Z11
KEGG
D05251
ChEMBL
ChEMBL1201589N
Chemical and physical data
Formula
C6450H9916N1714O2023S38
Molar mass
145058.53 g·mol−1
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Omalizumab, sold under the brand name Xolair, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives),[8][9] and immunoglobulin E-mediated food allergy.[10]
Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody which specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to the membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes.[11][12] Its primary adverse effect is anaphylaxis.
In 1987 Tanox filed its first patent application on the anti-IgE drug candidates. It took until 2003, in the United States until omalizumab was approved, in Europe until 2005 for moderate to severe persistent asthma, severe chronic rhinosinusitis with nasal polyps. In February 2024, the FDA approved it also to treat severe food allergy.
^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
^"Australian Public Assessment Report for Omalizumab" (PDF). Therapeutic Goods Administration. April 2021. Retrieved 5 January 2023.
^"AusPAR Xolair Omalizumab Novartis Pharmaceuticals Australia Pty Ltd PM-2014-03868-1-5" (PDF). Therapeutic Goods Administration. 22 June 2016. Retrieved 5 January 2023.
^"Regulatory Decision Summary - Xolair - Health Canada". Government of Canada. 14 July 2021. Retrieved 5 January 2023.
^Novartis Pharmaceuticals Canada Inc (26 September 2017). "Product Monograph: Pr Xolair Omalizumab" (PDF). Retrieved 5 January 2023.
^"Regulatory Decision Summary for Xolair". Drug and Health Products Portal. 8 February 2024. Retrieved 2 April 2024.
^"Xolair 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 18 August 2020. Retrieved 12 June 2021.
^ ab"Xolair- omalizumab injection, solution Xolair PFS- omalizumab injection, solution". DailyMed. 11 May 2020. Retrieved 6 December 2020.
^ ab"Xolair EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 12 June 2021.
^Cite error: The named reference FDA PR 20240216 was invoked but never defined (see the help page).
^Presta LG, Lahr SJ, Shields RL, Porter JP, Gorman CM, Fendly BM, et al. (1993). "Humanization of an Antibody Directed Against IgE". The Journal of Immunology. 151 (5): 2623–2632. doi:10.4049/jimmunol.151.5.2623. PMID 8360482.
^Schulman ES (October 2001). "Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders". Am J Respir Crit Care Med. 164 (8 Pt 2): S6–11. doi:10.1164/ajrccm.164.supplement_1.2103025. PMID 11704611.
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Rachid R, Gragg H, Little SV, Lakin P, Cianferoni A, et al. (March 2017). "Omalizumab facilitates rapid oral desensitization for peanut allergy". The Journal...
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