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| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Crizanlizumab
| DailyMedID = Crizanlizumab
| licence_US = Adakveo
| licence_US =
| pregnancy_AU = B1
| pregnancy_AU = B1
| pregnancy_AU_comment = <ref name="AusPAR: Crizanlizumab" /><ref name="Adakveo APM summary" />
| pregnancy_AU_comment = <ref name="AusPAR: Crizanlizumab" /><ref name="Adakveo APM summary" />
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| legal_US_comment =
| legal_US_comment =
| legal_EU = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Adakveo EPAR">{{cite web | title=Adakveo EPAR | website=European Medicines Agency | date=20 July 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/adakveo | access-date=5 March 2023}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web | title=Adakveo Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1476.htm | access-date=3 March 2023}}</ref>
| legal_EU_comment =
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
| legal_UN_comment =
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}}
}}


'''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]].<ref name="FDA PR" /> 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).<ref>{{cite journal |last1=Darbari |first1=Deepika S. |last2=Sheehan |first2=Vivien A. |last3=Ballas |first3=Samir K. |title=The vaso‐occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management |journal=European Journal of Haematology |date=September 2020 |volume=105 |issue=3 |pages=237–246 |doi=10.1111/ejh.13430 |pmid=32301178 |s2cid=215801719 |url=https://doi.org/10.1111/ejh.13430 |access-date=2 May 2022 |language=en |issn=0902-4441}}</ref>
'''Crizanlizumab''', sold under the brand name '''Adakveo''' among others, 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]].<ref name="FDA PR" /> 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).<ref>{{cite journal |last1=Darbari |first1=Deepika S. |last2=Sheehan |first2=Vivien A. |last3=Ballas |first3=Samir K. |title=The vaso‐occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management |journal=European Journal of Haematology |date=September 2020 |volume=105 |issue=3 |pages=237–246 |doi=10.1111/ejh.13430 |pmid=32301178 |s2cid=215801719 |url=https://doi.org/10.1111/ejh.13430 |access-date=2 May 2022 |issn=0902-4441}}</ref>

The most common side effects include joint pain, nausea, back pain, fever and abdominal (belly) pain.<ref name="Adakveo EPAR" />


The result of the Phase II SUSTAIN clinical trial was published in December 2016,<ref name=NEJM001>{{cite journal |vauthors=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 |title=Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease |journal=N. Engl. J. Med. |volume=376 |issue=5 |pages=429–439 |date=February 2017 |pmid=27959701 |pmc=5481200 |doi=10.1056/NEJMoa1611770 }}</ref> and in November 2019, crizanlizumab-tmca was approved in the United States.<ref name="FDA PR">{{cite press release | 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 U.S. [[Food and Drug Administration]] (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>
The result of the Phase II SUSTAIN clinical trial was published in December 2016,<ref name=NEJM001>{{cite journal |vauthors=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 |title=Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease |journal=N. Engl. J. Med. |volume=376 |issue=5 |pages=429–439 |date=February 2017 |pmid=27959701 |pmc=5481200 |doi=10.1056/NEJMoa1611770 }}</ref> and in November 2019, crizanlizumab-tmca was approved in the United States.<ref name="FDA PR">{{cite press release | 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 U.S. [[Food and Drug Administration]] (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>

== Medical uses ==
Crizanlizumab is [[indicated]] for the prevention of recurrent vaso occlusive crises in sickle cell disease patients aged 16 years and older.<ref name="Adakveo EPAR" /> It can be given as an add on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.<ref name="Adakveo EPAR" />


==Pathophysiology==
==Pathophysiology==
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==History==
==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.<ref name="FDA Snapshot" /> The trial was conducted at 60 sites in the United States, Brazil and Jamaica.<ref name="FDA Snapshot" />
The US [[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.<ref name="FDA Snapshot" /> The trial was conducted at 60 sites in the United States, Brazil and Jamaica.<ref name="FDA Snapshot" />


The FDA granted the application for crizanlizumab-tmca [[priority review]], [[breakthrough therapy]] designation, and [[orphan drug]] designation.<ref name="FDA PR" /> The FDA granted approval of Adakveo to [[Novartis]].<ref name="FDA PR" /><ref name="FDA Snapshot" />
The FDA granted the application for crizanlizumab-tmca [[priority review]], [[breakthrough therapy]] designation, and [[orphan drug]] designation.<ref name="FDA PR" /> The FDA granted approval of Adakveo to [[Novartis]].<ref name="FDA PR" /><ref name="FDA Snapshot" />
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* {{cite web| url = https://druginfo.nlm.nih.gov/drugportal/name/crizanlizumab | publisher = U.S. National Library of Medicine| work = Drug Information Portal| title = Crizanlizumab }}
* {{cite web| url = https://druginfo.nlm.nih.gov/drugportal/name/crizanlizumab | publisher = U.S. National Library of Medicine| work = Drug Information Portal| title = Crizanlizumab }}


{{monoclonals for immune system}}
{{Monoclonals for immune system}}
{{Portal bar | Medicine}}
{{Portal bar | Medicine}}


Revision as of 05:32, 5 March 2023

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 among others, 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.[5] 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).[6]

The most common side effects include joint pain, nausea, back pain, fever and abdominal (belly) pain.[3]

The result of the Phase II SUSTAIN clinical trial was published in December 2016,[7] and in November 2019, crizanlizumab-tmca was approved in the United States.[5][8][9] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]

Medical uses

Crizanlizumab is indicated for the prevention of recurrent vaso occlusive crises in sickle cell disease patients aged 16 years and older.[3] It can be given as an add on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.[3]

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.[11][12][13]

History

The US 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.[9] The trial was conducted at 60 sites in the United States, Brazil and Jamaica.[9]

The FDA granted the application for crizanlizumab-tmca priority review, breakthrough therapy designation, and orphan drug designation.[5] The FDA granted approval of Adakveo to Novartis.[5][9]

References

  1. ^ a b "AusPAR: Crizanlizumab". Therapeutic Goods Administration (TGA). 24 August 2021. Retrieved 4 September 2021.
  2. ^ a b "Adakveo". Therapeutic Goods Administration (TGA). 16 April 2021. Retrieved 6 September 2021.
  3. ^ a b c d "Adakveo EPAR". European Medicines Agency. 20 July 2020. Retrieved 5 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ^ "Adakveo Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  5. ^ 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.Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ Darbari, Deepika S.; Sheehan, Vivien A.; Ballas, Samir K. (September 2020). "The vaso‐occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management". European Journal of Haematology. 105 (3): 237–246. doi:10.1111/ejh.13430. ISSN 0902-4441. PMID 32301178. S2CID 215801719. Retrieved 2 May 2022.
  7. ^ 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.
  8. ^ "Drug Approval Package: Adakveo (crizanlizumab-tmca)". U.S. Food and Drug Administration (FDA). 17 December 2019. Retrieved 22 January 2020.
  9. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.
  11. ^ 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.
  12. ^ 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.
  13. ^ 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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