Crizanlizumab: Difference between revisions
Content deleted Content added
update infobox |
→top: add first-in-class |
||
| Line 96: | Line 96: | ||
Crizanlizumab is a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for those 16 years and older.<ref name="FDA PR" /> |
Crizanlizumab is a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for those 16 years and older.<ref name="FDA PR" /> |
||
In November 2019, crizanlizumab-tmca was approved in the United States.<ref name="FDA PR">{{cite web | title=FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease | website=U.S. [[Food and Drug Administration]] (FDA) | date=15 November 2019 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-patients-painful-complication-sickle-cell-disease | archive-url=https://web.archive.org/web/20191121062636/https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-patients-painful-complication-sickle-cell-disease | archive-date=21 November 2019 | url-status=live | access-date=20 November 2019}}{{PD-notice}}</ref><ref>{{cite web | title=Drug Approval Package: Adakveo (crizanlizumab-tmca) | website=U.S. [[Food and Drug Administration]] (FDA) | date=17 December 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761128Orig1s000TOC.cfm | access-date=22 January 2020}}</ref><ref name="FDA Snapshot">{{cite web | title=Drug Trials Snapshots Adakveo | website=U.S. [[Food and Drug Administration]] (FDA) | date=15 November 2019 | url=http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo | access-date=26 January 2020 | archive-url=https://web.archive.org/web/20200124193905/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo | archive-date= 24 January 2020}} {{PD-notice}}</ref> |
In November 2019, crizanlizumab-tmca was approved in the United States.<ref name="FDA PR">{{cite web | title=FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease | website=U.S. [[Food and Drug Administration]] (FDA) | date=15 November 2019 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-patients-painful-complication-sickle-cell-disease | archive-url=https://web.archive.org/web/20191121062636/https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-patients-painful-complication-sickle-cell-disease | archive-date=21 November 2019 | url-status=live | access-date=20 November 2019}}{{PD-notice}}</ref><ref>{{cite web | title=Drug Approval Package: Adakveo (crizanlizumab-tmca) | website=U.S. [[Food and Drug Administration]] (FDA) | date=17 December 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761128Orig1s000TOC.cfm | access-date=22 January 2020}}</ref><ref name="FDA Snapshot">{{cite web | title=Drug Trials Snapshots Adakveo | website=U.S. [[Food and Drug Administration]] (FDA) | date=15 November 2019 | url=http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo | access-date=26 January 2020 | archive-url=https://web.archive.org/web/20200124193905/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo | archive-date= 24 January 2020}} {{PD-notice}}</ref> The FDA considers it to be a first-in-class medication.<ref>{{cite web | title=New Drug Therapy Approvals 2019 | website=U.S. Food and Drug Administration | date=31 December 2019 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019 | access-date=15 September 2020}}</ref> |
||
==Pathophysiology== |
==Pathophysiology== |
||
Revision as of 19:10, 15 September 2020
| 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 |
|
| Routes of administration | IV |
| ATC code | |
| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number | |
| PubChem SID | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6458H9948N1712O2050S58 |
| Molar mass | 146232.04 g·mol−1 |
Crizanlizumab, (brand name Adakveo), is a monoclonal antibody developed by Novartis targeted towards P-selectin. It was announced by the company as an effective drug to prevent vaso-occlusive crisis in patients with sickle cell anemia. The result of the Phase II SUSTAIN clinical trial was published in December 2016.[2]
Crizanlizumab is a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for those 16 years and older.[3]
In November 2019, crizanlizumab-tmca was approved in the United States.[3][4][5] The FDA considers it to be a first-in-class medication.[6]
Pathophysiology
P-selectin molecules are present on the surface of vascular endothelial cells and have been linked to sickle cell vaso-occlusive crises.[7][8][9]
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.[5] The trial was conducted at 60 sites in the United States, Brazil and Jamaica.[5]
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][5]
References
- ^ "Crizanlizumab (Adakveo) Use During Pregnancy". Drugs.com. 4 December 2019. Retrieved 23 January 2020.
- ^ 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.
- ^ 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). 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.
- ^ "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.
 | This drug article relating to the blood and blood forming organs is a stub. You can help Wikipedia by expanding it. |