Crizanlizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | selectin P |
| Clinical data | |
| Trade names | Adakveo |
| Other names | SEG101, SelG1, crizanlizumab-tmca |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620010 |
| License data |
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| Pregnancy category | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6458H9948N1712O2050S58 |
| Molar mass | 146232.04 g·mol−1 |
Crizanlizumab, sold under the brand name Adakveo & Ryverna both by Novartis, is a monoclonal antibody medication that binds to P-selectin. It is a drug used to reduce the frequency of vaso-occlusive crisis in people aged 16 years and older who have sickle cell anemia.[3] Vaso-occlusive crisis is a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells (red cells are usually round and flexible, but sometimes many red cells in a person with sickle cell anemia will become rigid and crescent-shaped due to polymerization of hemoglobin).[citation needed]
The result of the Phase II SUSTAIN clinical trial was published in December 2016,[4] and in November 2019, crizanlizumab-tmca was approved in the United States.[3][5][6] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
Pathophysiology
P-selectin molecules are present on the surface of activated platelets and vascular endothelial cells and have been linked to sickle cell vaso-occlusive crises.[8][9][10]
History
The U.S. Food and Drug Administration (FDA) approved crizanlizumab based on evidence from one clinical trial (Trial 1/NCT01895361) of 132 patients with sickle cell diseases who had a history of vaso-occlusive crisis.[6] The trial was conducted at 60 sites in the United States, Brazil and Jamaica.[6]
The FDA granted the application for crizanlizumab-tmca priority review, breakthrough therapy designation, and orphan drug designation.[3] The FDA granted approval of Adakveo to Novartis.[3][6]
References
- ^ a b "AusPAR: Crizanlizumab". Therapeutic Goods Administration (TGA). 24 August 2021. Retrieved 4 September 2021.
- ^ a b "Adakveo". Therapeutic Goods Administration (TGA). 16 April 2021. Retrieved 6 September 2021.
- ^ a b c d "FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease". U.S. Food and Drug Administration (FDA) (Press release). 15 November 2019. Archived from the original on 21 November 2019. Retrieved 20 November 2019.
This article incorporates text from this source, which is in the public domain.
- ^ Ataga KI, Kutlar A, Kanter J, Liles D, Cancado R, Friedrisch J, Guthrie TH, Knight-Madden J, Alvarez OA, Gordeuk VR, Gualandro S, Colella MP, Smith WR, Rollins SA, Stocker JW, Rother RP (February 2017). "Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease". N. Engl. J. Med. 376 (5): 429–439. doi:10.1056/NEJMoa1611770. PMC 5481200. PMID 27959701.
- ^ "Drug Approval Package: Adakveo (crizanlizumab-tmca)". U.S. Food and Drug Administration (FDA). 17 December 2019. Retrieved 22 January 2020.
- ^ a b c d "Drug Trials Snapshots Adakveo". U.S. Food and Drug Administration (FDA). 15 November 2019. Archived from the original on 24 January 2020. Retrieved 26 January 2020. This article incorporates text from this source, which is in the public domain.
- ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.
- ^ Manwani D, Frenette PS (December 2013). "Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies". Blood. 122 (24): 3892–8. doi:10.1182/blood-2013-05-498311. PMC 3854110. PMID 24052549.
- ^ Manwani D, Frenette PS (December 2013). "Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies". Hematology Am Soc Hematol Educ Program. 2013: 362–9. doi:10.1182/asheducation-2013.1.362. PMC 3854110. PMID 24319205.
- ^ Riley TR, Boss A, McClain D, Riley TT (July 2018). "Review of Medication Therapy for the Prevention of Sickle Cell Crisis". P T. 43 (7): 417–437. PMC 6027858. PMID 30013299.
External links
- "Crizanlizumab". Drug Information Portal. U.S. National Library of Medicine.
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