Crizanlizumab

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Crizanlizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
Targetselectin P
Names
Trade namesAdakveo, Ryverna, others
Other namesSEG101, SelG1, crizanlizumab-tmca
Clinical data
Drug classP-selectin inhibitor[1]
Main usesSickle cell disease[2]
Side effectsJoint pain, nausea, fever, abdominal pain[1]
Pregnancy
category
Routes of
use
Intravenous
Typical dose5 mg/kg[2]
External links
AHFS/Drugs.comMonograph
US NLMCrizanlizumab
MedlinePlusa620010
Legal
License data
Legal status
Chemical and physical data
FormulaC6458H9948N1712O2050S58
Molar mass146232.04 g·mol−1

Crizanlizumab, sold under the brand name Adakveo among others, is a medication used to treat sickle cell disease.[2] Specifically it is used to reduce the frequency of vaso-occlusive crisis in people over 15 years old.[2] It is given by injection into vein.[2]

Common side effects include joint pain, nausea, fever, and abdominal pain.[1] Other side effects may include infusion reactions.[2] Use in pregnancy may harm the baby.[2] It is a monoclonal antibody that binds to and blocks P-selectin, decreasing the attaching of cells to the inside of blood vessels.[1]

Crizanlizumab was approved for medical use in the United States in 2019 and Europe in 2020.[2][1] In the United Kingdom 100 mg costs the NHS about £1,000 as of 2021.[5] This amount in the United States is about 2,400 USD.[6]

Medical use

Dosage

It is given at a dose of 5 mg/kg at 0 and 2 weeks, followed by every 4 weeks.[2]

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.[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.[10] The trial was conducted at 60 sites in the United States, Brazil and Jamaica.[10]

The FDA granted the application for crizanlizumab-tmca priority review, breakthrough therapy designation, and orphan drug designation.[11] The FDA granted approval of Adakveo to Novartis.[11][10]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[12]

References

  1. 1.0 1.1 1.2 1.3 1.4 "Adakveo". Archived from the original on 14 November 2021. Retrieved 7 January 2022.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "DailyMed - ADAKVEO- crizanlizumab injection". dailymed.nlm.nih.gov. Archived from the original on 8 May 2021. Retrieved 7 January 2022.
  3. 3.0 3.1 "AusPAR: Crizanlizumab". Therapeutic Goods Administration (TGA). 24 August 2021. Archived from the original on 4 September 2021. Retrieved 4 September 2021.
  4. 4.0 4.1 "Adakveo". Therapeutic Goods Administration (TGA). 16 April 2021. Archived from the original on 6 September 2021. Retrieved 6 September 2021.
  5. "Crizanlizumab". SPS - Specialist Pharmacy Service. 6 December 2016. Archived from the original on 11 January 2022. Retrieved 7 January 2022.
  6. "Crizanlizumab Prices and Crizanlizumab Coupons - GoodRx". GoodRx. Retrieved 7 January 2022.
  7. 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.
  8. 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.
  9. 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.
  10. 10.0 10.1 10.2 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  11. 11.0 11.1 "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.Public Domain This article incorporates text from this source, which is in the public domain.
  12. "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.

External links

External sites:
Identifiers: