Chemistry:Caplacizumab
| Monoclonal antibody | |
|---|---|
| Type | [[[Biology:Single domain antibody|Single domain antibody]] |
| Source | Humanized |
| Target | von Willebrand factor (VWF) |
| Clinical data | |
| Trade names | Cablivi |
| Other names | ALX-0081, caplacizumab-yhdp |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619030 |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous, subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C1213H1891N357O380S10 |
| Molar mass | 27876.19 g·mol−1 |
Caplacizumab (INN; trade name Cablivi) is a bivalent single-domain antibody (VHH) designed for the treatment of thrombotic thrombocytopenic purpura (TTP) and thrombosis.[4][5][6][7]
This drug was developed by Ablynx NV.[8] On 30 August 2018, it was approved in the European Union for the "treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression".[9]
It is an anti-von Willebrand factor humanized immunoglobulin.[10] It acts by blocking platelet aggregation to reduce organ injury due to ischemia.[10] Results of the phase II TITAN trial have been reported.[10]
Common adverse effects include injection site reactions, reported in 3–6% of patients in the HERCULES and TITAN trials.[11]
In February 2019, caplacizumab-yhdp (Cablivi, Ablynx NV) was approved in the United States for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP). The drug is used in combination with plasma exchange and immunosuppressive therapy.[12][13] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[14]
References
- ↑ "Cablivi Product information". 25 April 2012. https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=98606.
- ↑ "Summary Basis of Decision (SBD) for Cablivi". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00477&lang=en.
- ↑ "Cablivi 10 mg powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". 22 June 2020. https://www.medicines.org.uk/emc/product/10347.
- ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Caplacizumab, American Medical Association.
- ↑ World Health Organization (WHO) (2011). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 106". WHO Drug Information 25 (4). https://www.who.int/medicines/publications/druginformation/innlists/Final_PL106.pdf.
- ↑ "A critical evaluation of caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura". Expert Review of Hematology 13 (11): 1153–1164. November 2020. doi:10.1080/17474086.2020.1819230. PMID 32876503.
- ↑ "Caplacizumab to treat immune-mediated thrombotic thrombocytopenic purpura". Drugs of Today (Barcelona, Spain) 55 (6): 367–376. June 2019. doi:10.1358/dot.2019.55.6.2989843. PMID 31250841.
- ↑ Clinical trial number NCT02553317 for "A Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura (HERCULES)" at ClinicalTrials.gov
- ↑ "Cablivi EPAR". https://www.ema.europa.eu/en/medicines/human/EPAR/cablivi.
- ↑ 10.0 10.1 10.2 Immune Drug Tackles Microvascular Thrombosis Disorder. February 2016
- ↑ FDA Professional Drug Information
- ↑ "FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder". U.S. Food and Drug Administration (FDA) (Press release). 6 February 2019. Archived from the original on 23 November 2019. Retrieved 22 November 2019.
This article incorporates text from this source, which is in the public domain.
- ↑ "Drug Trials Snapshots: Cablivi". 11 February 2019. https://www.fda.gov/drugs/drug-trials-snapshots-cablivi. This article incorporates text from this source, which is in the public domain.
- ↑ "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.
External links
- "Caplacizumab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/caplacizumab.
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