Omalizumab
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 |
| Biosimilars | Omalizumab-igec,[1] Omlyclo[1][2][3] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a603031 |
| License data |
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| Pregnancy category |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 26 days |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C6450H9916N1714O2023S38 |
| Molar mass | 145058.53 g·mol−1 |
| (what is this?) (verify) | |
Omalizumab, sold under the brand name Xolair among others, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives),[10][11] and immunoglobulin E-mediated food allergy.[12]
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.[13][14] Its primary adverse effect is anaphylaxis.
In 1987, Tanox filed its first patent application on the anti-IgE drug candidate.[15] Omalizumab was approved for medical use in the United States in June 2003, and authorized in the European Union in October 2005.
- ^ a b fda.gov
- ^ a b Cite error: The named reference
Omlyclo EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Omlyclo EU PIwas invoked but never defined (see the help page). - ^ "Australian Public Assessment Report for Omalizumab" (PDF). Therapeutic Goods Administration. April 2021. Archived (PDF) from the original on 6 January 2023. Retrieved 5 January 2023.
- ^ "AusPAR Xolair Omalizumab Novartis Pharmaceuticals Australia Pty Ltd PM-2014-03868-1-5" (PDF). Therapeutic Goods Administration. 22 June 2016. Archived (PDF) from the original on 13 June 2021. Retrieved 5 January 2023.
- ^ "Regulatory Decision Summary - Xolair - Health Canada". Government of Canada. 14 July 2021. Archived from the original on 6 January 2023. Retrieved 5 January 2023.
- ^ Novartis Pharmaceuticals Canada Inc (26 September 2017). "Product Monograph: Pr Xolair Omalizumab" (PDF). Archived (PDF) from the original on 28 August 2021. Retrieved 5 January 2023.
- ^ "Regulatory Decision Summary for Xolair". Drug and Health Products Portal. 8 February 2024. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
- ^ "Xolair 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 18 August 2020. Archived from the original on 13 June 2021. Retrieved 12 June 2021.
- ^ a b "Xolair- omalizumab injection, solution; Xolair PFS- omalizumab injection, solution; Xolair- omalizumab injection, solution". DailyMed. 20 November 2024. Archived from the original on 28 November 2020. Retrieved 6 December 2020.
- ^ a b "Xolair EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 13 June 2021. Retrieved 12 June 2021.
- ^ Cite error: The named reference
FDA PR 20240216was 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.
- ^ Cite error: The named reference
The Scientistwas invoked but never defined (see the help page).