Biology:Crizanlizumab

From HandWiki
Crizanlizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
Targetselectin P
Clinical data
Trade namesAdakveo
Other namesSEG101, SelG1, crizanlizumab-tmca
AHFS/Drugs.comMonograph
MedlinePlusa620010
License data
Pregnancy
category
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6458H9948N1712O2050S58
Molar mass146232.04 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).[4]

The result of the Phase II SUSTAIN clinical trial was published in December 2016,[5] and in November 2019, crizanlizumab-tmca was approved in the United States.[3][6][7] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8]

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.[9][10][11]

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.[7] The trial was conducted at 60 sites in the United States, Brazil and Jamaica.[7]

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][7]

References

  1. 1.0 1.1 "AusPAR: Crizanlizumab". 24 August 2021. https://www.tga.gov.au/auspar/auspar-crizanlizumab. 
  2. 2.0 2.1 "Adakveo". 16 April 2021. https://www.tga.gov.au/apm-summary/adakveo. 
  3. 3.0 3.1 3.2 3.3 "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.
  4. Darbari, Deepika S.; Sheehan, Vivien A.; Ballas, Samir K. (September 2020). "The vaso‐occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management" (in en). European Journal of Haematology 105 (3): 237–246. doi:10.1111/ejh.13430. ISSN 0902-4441. PMID 32301178. https://doi.org/10.1111/ejh.13430. Retrieved 2 May 2022. 
  5. "Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease". N. Engl. J. Med. 376 (5): 429–439. February 2017. doi:10.1056/NEJMoa1611770. PMID 27959701. 
  6. "Drug Approval Package: Adakveo (crizanlizumab-tmca)". 17 December 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761128Orig1s000TOC.cfm. 
  7. 7.0 7.1 7.2 7.3 "Drug Trials Snapshots Adakveo". 15 November 2019. http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo.  This article incorporates text from this source, which is in the public domain.
  8. "New Drug Therapy Approvals 2019". 31 December 2019. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019. 
  9. "Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies". Blood 122 (24): 3892–8. December 2013. doi:10.1182/blood-2013-05-498311. PMID 24052549. 
  10. "Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies". Hematology Am Soc Hematol Educ Program 2013: 362–9. December 2013. doi:10.1182/asheducation-2013.1.362. PMID 24319205. 
  11. "Review of Medication Therapy for the Prevention of Sickle Cell Crisis". P T 43 (7): 417–437. July 2018. PMID 30013299. 

External links