Mavacamten

{{Short description|Chemical compound}}

{{Use American English|date=April 2022}}

{{Use dmy dates|date=June 2023}}

{{Infobox drug

| image = Mavacamten.svg

| width =

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| caption =

| pronounce =

| tradename = Camzyos

| Drugs.com = {{drugs.com|monograph|mavacamten}}

| MedlinePlus = a622047

| DailyMedID = Mavacamten

| image_class = skin-invert-image

| pregnancy_AU = D

| pregnancy_AU_comment =

| pregnancy_category=

| routes_of_administration = By mouth

| class = Cardiac myosin inhibitor

| ATC_prefix = C01

| ATC_suffix = EB24

| ATC_supplemental =

| legal_AU = S4

| legal_AU_comment = {{cite web | title=Camzyos | publisher=Therapeutic Goods Administration (TGA) | date=13 October 2022 | url=https://www.tga.gov.au/resources/auspmd/camzyos | access-date=28 April 2023 | archive-date=5 February 2023 | archive-url=https://web.archive.org/web/20230205203431/https://www.tga.gov.au/resources/auspmd/camzyos | url-status=live }}{{cite web | title=Camzyos (Bristol-Myers Squibb Australia Pty Ltd) | publisher=Therapeutic Goods Administration (TGA) | date=7 October 2022 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/camzyos-bristol-myers-squibb-australia-pty-ltd | access-date=28 April 2023 | archive-date=13 November 2022 | archive-url=https://web.archive.org/web/20221113202648/https://www.tga.gov.au/resources/prescription-medicines-registrations/camzyos-bristol-myers-squibb-australia-pty-ltd | url-status=live }}

| legal_BR = C1

| legal_BR_comment = {{Cite web |author=Anvisa |author-link=Brazilian Health Regulatory Agency |date=2023-03-31 |title=RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial |trans-title=Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control|url=https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 |url-status=live |archive-url=https://web.archive.org/web/20230803143925/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 |archive-date=2023-08-03 |access-date=2023-08-16 |publisher=Diário Oficial da União |language=pt-BR |publication-date=2023-04-04}}

| legal_CA = Rx-only

| legal_CA_comment = {{cite web | title=Camzyos Product information | website=Health Canada | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=102157 | access-date=2 January 2023 | archive-date=3 January 2023 | archive-url=https://web.archive.org/web/20230103054116/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=102157 | url-status=live }}{{cite web | title=Summary Basis of Decision for Camzyos | website=Health Canada | date=12 April 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684173887386 | access-date=5 June 2023 | archive-date=3 August 2023 | archive-url=https://web.archive.org/web/20230803054858/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684173887386 | url-status=live }}{{cite web | title=Details for: Camzyos | website=Health Canada | date=9 January 2023 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102157 | access-date=3 March 2024 | archive-date=3 March 2024 | archive-url=https://web.archive.org/web/20240303062051/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102157 | url-status=live }}

| legal_DE =

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| legal_US = Rx-only

| legal_US_comment = {{cite web | title=Camzyos- mavacamten capsule, gelatin coated | website=DailyMed | date=28 April 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=669c936b-3ee6-4e36-8a22-79dd11b1255b | access-date=15 May 2022 | archive-date=3 July 2022 | archive-url=https://web.archive.org/web/20220703055430/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=669c936b-3ee6-4e36-8a22-79dd11b1255b | url-status=live }}

| legal_EU = Rx-only

| legal_EU_comment = {{cite web | title=Camzyos EPAR | website=European Medicines Agency (EMA) | date=24 July 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/camzyos | access-date=2 August 2023 | archive-date=3 August 2023 | archive-url=https://web.archive.org/web/20230803055208/https://www.ema.europa.eu/en/medicines/human/EPAR/camzyos | url-status=live }}

| legal_UN =

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| bioavailability =

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| CAS_number = 1642288-47-8

| CAS_supplemental =

| PubChem = 117761397

| IUPHAR_ligand =

| DrugBank = DB14921

| ChemSpiderID =

| UNII = QX45B99R3J

| KEGG = D12265

| ChEBI =

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| NIAID_ChemDB =

| PDB_ligand =

| synonyms = MYK-461

| IUPAC_name = 6-[[(1S)-1-phenylethyl]amino]-3-propan-2-yl-1H-pyrimidine-2,4-dione

| C = 15 | H = 19 | N = 3 | O = 2

| SMILES = CC(C)N1C(=O)NC(N[C@@H](C)C2=CC=CC=C2)=CC1=O

| StdInChI = 1S/C15H19N3O2/c1-10(2)18-14(19)9-13(17-15(18)20)16-11(3)12-7-5-4-6-8-12/h4-11,16H,1-3H3,(H,17,20)/t11-/m0/s1

| StdInChI_comment =

| StdInChIKey = RLCLASQCAPXVLM-NSHDSACASA-N

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}}

Mavacamten, sold under the brand name Camzyos, is a medication used to treat obstructive hypertrophic cardiomyopathy.

Mavacamten is a small-molecule allosteric {{cite journal | vauthors = Edelberg JM, Sehnert AJ, Mealiffe ME, Del Rio CL, McDowell R | title = The Impact of Mavacamten on the Pathophysiology of Hypertrophic Cardiomyopathy: A Narrative Review | journal = American Journal of Cardiovascular Drugs | volume = 22 | issue = 5 | pages = 497–510 | date = September 2022 | pmid = 35435607 | pmc = 9467968 | doi = 10.1007/s40256-022-00532-x }} and cardiac myosin inhibitor. It was developed by MyoKardia, a subsidiary of Bristol Myers Squibb.{{cite press release | title=Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company's Leading Cardiovascular Franchise | publisher=Bristol Myers Squibb | via=Business Wire | date=17 November 2020 | url=https://www.businesswire.com/news/home/20201117005811/en/Bristol-Myers-Squibb-Completes-Acquisition-of-MyoKardia-Strengthening-Company%E2%80%99s-Leading-Cardiovascular-Franchise | access-date=29 April 2022 | archive-date=29 April 2022 | archive-url=https://web.archive.org/web/20220429175608/https://www.businesswire.com/news/home/20201117005811/en/Bristol-Myers-Squibb-Completes-Acquisition-of-MyoKardia-Strengthening-Company%E2%80%99s-Leading-Cardiovascular-Franchise | url-status=live }} In clinical studies, mavacamten has demonstrated significant efficacy in reducing cardiac muscle contractility by targeting the sarcomere hypercontractility that is one of the characteristics of hypertrophic cardiomyopathy and inhibits excessive myosin actin cross-bridge formation, shifting the overall myosin population towards an energy-sparing, recruitable, super-relaxed state.

Mavacamten was approved for medical use in the United States in April 2022.{{cite press release |url=https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-improve-heart-function-adults-rare-heart-condition |title=FDA approves new drug to improve heart function in adults with rare heart condition |publisher=U.S. Food and Drug Administration (FDA) |date=29 April 2022 |access-date=29 November 2022 |archive-date=29 November 2022 |archive-url=https://web.archive.org/web/20221129094909/https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-improve-heart-function-adults-rare-heart-condition |url-status=live }}{{cite news |url=https://www.reuters.com/business/healthcare-pharmaceuticals/fda-approves-bristol-myers-heart-disease-drug-2022-04-29/ |title=FDA approves Bristol Myers' oral heart disease drug |work=Reuters |date=29 April 2022 |access-date=29 November 2022 |archive-date=29 November 2022 |archive-url=https://web.archive.org/web/20221129094908/https://www.reuters.com/business/healthcare-pharmaceuticals/fda-approves-bristol-myers-heart-disease-drug-2022-04-29/ |url-status=live }}{{cite press release | title=U.S. Food and Drug Administration Approves Camzyos (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms | publisher=Bristol Myers Squibb | via=Business Wire | date=28 April 2022 | url=https://www.businesswire.com/news/home/20220428006368/en | access-date=29 April 2022 | archive-date=29 April 2022 | archive-url=https://web.archive.org/web/20220429002313/https://www.businesswire.com/news/home/20220428006368/en/ | url-status=live }} The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.{{cite web | title=Advancing Health Through Innovation: New Drug Therapy Approvals 2022 | website=U.S. Food and Drug Administration (FDA) | date=10 January 2023 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 | access-date=22 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 | url-status=dead }} {{PD-notice}}{{cite report | title=New Drug Therapy Approvals 2022 | website=U.S. Food and Drug Administration (FDA) | date=January 2024 | url=https://www.fda.gov/media/164429/download | format=PDF | access-date=14 January 2024 | archive-url=https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download | archive-date=14 January 2024 | url-status=dead }} {{PD-notice}}

Medical uses

Mavacamten is indicated for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

Adverse effects

The US prescribing information for mavacamten contains a boxed warning regarding heart failure. Mavacamten reduces the left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

History

Mavacamten was granted orphan drug designation by the US Food and Drug Administration (FDA).{{cite web | title=Mavacamten Orphan Drug Designations and Approvals | website=U.S. Food and Drug Administration (FDA) | date=27 April 2016 | url=https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=515015 | access-date=29 April 2022 | archive-date=3 July 2022 | archive-url=https://web.archive.org/web/20220703055440/https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=515015 | url-status=live }}

Society and culture

= Legal status =

On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Camzyos, intended for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.{{cite web | title=Camzyos: Pending EC decision | website=European Medicines Agency (EMA) | date=26 April 2023 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/camzyos | access-date=27 April 2023 | archive-date=29 April 2023 | archive-url=https://web.archive.org/web/20230429041755/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/camzyos | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. In June 2023, the European Commission approved Mavacamten.{{cite web | title=Camzyos | website=Union Register of medicinal products | date=27 June 2023 | url=https://ec.europa.eu/health/documents/community-register/html/h1716.htm | access-date=2 August 2023 | archive-date=3 August 2023 | archive-url=https://web.archive.org/web/20230803054509/https://ec.europa.eu/health/documents/community-register/html/h1716.htm | url-status=live }}{{cite web |last=Priyan |first=Vishnu |date=27 June 2023 |title=EC approves BMS' Camzyos for hypertrophic cardiomyopathy |url=https://www.pharmaceutical-technology.com/news/ec-approves-bms-camzyos/ |access-date=27 June 2023 |website=Pharmaceutical Technology |archive-date=27 June 2023 |archive-url=https://web.archive.org/web/20230627105757/https://www.pharmaceutical-technology.com/news/ec-approves-bms-camzyos/ |url-status=live }}

Mavacamten is approved for use in the US,{{cite web |date=29 April 2022 |title=FDA approves new drug to improve heart function in adults with rare heart condition |url=https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-improve-heart-function-adults-rare-heart-condition |publisher=U.S. Food and Drug Administration (FDA) |access-date=29 November 2022 |archive-date=29 November 2022 |archive-url=https://web.archive.org/web/20221129094909/https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-improve-heart-function-adults-rare-heart-condition |url-status=live }} Canada,{{cite press release |title=Health Canada Approves Camzyos (mavacamten capsules) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy |url=https://www.bms.com/ca/en/media/press-release-listing/2022-11-10-press-release.html |date=10 November 2022 |access-date=27 June 2023 |website=Bristol Myers Squibb |archive-date=27 June 2023 |archive-url=https://web.archive.org/web/20230627114649/https://www.bms.com/ca/en/media/press-release-listing/2022-11-10-press-release.html |url-status=live }} Australia,{{cite web | title=Camzyos | publisher=Therapeutic Goods Administration (TGA) | date=13 October 2022 | url=https://www.tga.gov.au/resources/auspmd/camzyos | access-date=28 June 2023 | archive-date=5 February 2023 | archive-url=https://web.archive.org/web/20230205203431/https://www.tga.gov.au/resources/auspmd/camzyos | url-status=live }} South Korea,{{cite web |title=의약품안전나라 |url=https://nedrug.mfds.go.kr/ |access-date=27 June 2023 |website=Ministry of Food and Drug Safety |language=ko |archive-date=2 July 2023 |archive-url=https://web.archive.org/web/20230702052022/https://nedrug.mfds.go.kr/ |url-status=live }} Singapore,{{cite web |title=LianBio Announces Marketing Approval of Camzyos (mavacamten) in Singapore |url=https://www.biospace.com/article/lianbio-announces-marketing-approval-of-camzyos-mavacamten-in-singapore/ |access-date=27 June 2023 |website=BioSpace |archive-date=27 June 2023 |archive-url=https://web.archive.org/web/20230627114649/https://www.biospace.com/article/lianbio-announces-marketing-approval-of-camzyos-mavacamten-in-singapore/ |url-status=live }} Switzerland,{{cite web |title=Camzyos, Hartkapseln (Mavacamtenum) |url=https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/camzyos-hartkapseln-mavacamtenum.html |access-date=27 June 2023 |website=Swissmedic |archive-date=27 June 2023 |archive-url=https://web.archive.org/web/20230627114651/https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/camzyos-hartkapseln-mavacamtenum.html |url-status=live }} Brazil{{cite web |title=Camzyos (mavacanteno): novo registro |url=https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/camzyos-r-mavacanteno-novo-registro |access-date=27 June 2023 |website=Agência Nacional de Vigilância Sanitária - Anvisa |language=pt-br |archive-date=27 June 2023 |archive-url=https://web.archive.org/web/20230627114647/https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/camzyos-r-mavacanteno-novo-registro |url-status=live }} and Macau.{{cite press release | title=LianBio Announces Marketing Approval of Camzyos (mavacamten) in the Macau Special Administrative Region (SAR) of China | publisher=LianBio | via=GlobeNewswire | date=11 May 2023 | url=https://www.globenewswire.com/en/news-release/2023/05/11/2666545/0/en/LianBio-Announces-Marketing-Approval-of-CAMZYOS-mavacamten-in-the-Macau-Special-Administrative-Region-SAR-of-China.html | access-date=28 June 2023 | archive-date=28 June 2023 | archive-url=https://web.archive.org/web/20230628221049/https://www.globenewswire.com/en/news-release/2023/05/11/2666545/0/en/LianBio-Announces-Marketing-Approval-of-CAMZYOS-mavacamten-in-the-Macau-Special-Administrative-Region-SAR-of-China.html | url-status=live }}

= Names =

Mavacamten is the international nonproprietary name (INN).{{cite journal | vauthors = ((World Health Organization)) | year = 2017 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78 | journal = WHO Drug Information | volume = 31 | issue = 3 | page = | hdl = 10665/330961 | hdl-access = free | author-link = World Health Organization }}

References

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Further reading

  • {{cite journal | vauthors = Xie J, Wang Y, Xu Y, Fine JT, Lam J, Garrison LP | title = Assessing health-related quality-of-life in patients with symptomatic obstructive hypertrophic cardiomyopathy: EQ-5D-based utilities in the EXPLORER-HCM trial | journal = Journal of Medical Economics | volume = 25 | issue = 1 | pages = 51–58 | date = 2022 | pmid = 34907813 | doi = 10.1080/13696998.2021.2011301 | title-link = doi | doi-access = free }}