mavrilimumab

{{Short description|Monoclonal antibody}}

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| target = GM-CSF receptor alpha chain

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Mavrilimumab is a human monoclonal antibody{{cite web|title=Statement On A Nonproprietary Name Adopted By The USAN Council: Mavrilimumab|publisher=American Medical Association|url=http://www.ama-assn.org/resources/doc/usan/mavrilimumab.pdf |archive-url=https://web.archive.org/web/20120928202943/http://www.ama-assn.org/resources/doc/usan/mavrilimumab.pdf |archive-date=2012-09-28 }} that inhibits human granulocyte macrophage colony-stimulating factor receptor (GM-CSF-R).{{cite journal | vauthors = Burmester GR, Feist E, Sleeman MA, Wang B, White B, Magrini F | title = Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study | journal = Annals of the Rheumatic Diseases | volume = 70 | issue = 9 | pages = 1542–9 | date = September 2011 | pmid = 21613310 | pmc = 3147227 | doi = 10.1136/ard.2010.146225 }}

Mavrilimumab was discovered as CAM-3001 by Cambridge Antibody Technology and is being developed by MedImmune, Inc. as an investigational drug for the treatment of rheumatoid arthritis

Mavrilimumab has been studied in a phase 1 dose-ranging trial and a phase 2a clinical trial, both sponsored by Medimmune.{{cite journal | vauthors = Burmester GR, Weinblatt ME, McInnes IB, Porter D, Barbarash O, Vatutin M, Szombati I, Esfandiari E, Sleeman MA, Kane CD, Cavet G, Wang B, Godwood A, Magrini F | display-authors = 6 | collaboration = EARTH Study Group | title = Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis | journal = Annals of the Rheumatic Diseases | volume = 72 | issue = 9 | pages = 1445–52 | date = September 2013 | pmid = 23234647 | pmc = 3756523 | doi = 10.1136/annrheumdis-2012-202450 }} The phase 2a trial, which studied mavrilimumab doses of up to 100 mg, reported that 55.7% of subjects met the primary endpoint of a ≥1.2 decrease from baseline in disease activity scores at week 12 (vs. only 34.7% of placebo subjects).

In 2013, two further clinical studies were reported to be underway in rheumatoid arthritis patients to investigate these effects further.{{cite journal | vauthors = Di Franco M, Gerardi MC, Lucchino B, Conti F | title = Mavrilimumab: an evidence based review of its potential in the treatment of rheumatoid arthritis | journal = Core Evidence | volume = 9 | pages = 41–8 | date = 12 March 2014 | pmid = 24648832 | doi = 10.2147/CE.S39770 | pmc = 3958547 | doi-access = free }}

In early 2017 the phase IIb study was reported to be showing promising results.{{cite web | first = Nancy | last = Walsh | name-list-style = vanc | work = MedPage Today | date = February 21, 2017 | url = http://www.medpagetoday.com/mastery-of-medicine/rheumatology-mastery-in-ra/63286 | title = Agent that Targets GM-CSF Shows Promise in RA | quote = Novel monoclonal antibody was rapidly effective in mild-to-moderate disease }}

In 2017, Kiniksa licensed Mavrilimumab from MedImmune.{{Cite web|url=https://investors.kiniksa.com/node/7611/html|title = SEC Filing | Kiniksa Pharmaceuticals}}

It was studied in 2020 to see if it could improve the prognosis for patients with COVID-19 pneumonia and systemic hyperinflammation. One small study indicated some beneficial effects of treatment with mavrilimumab compared with those who were not.{{cite journal |vauthors=De Luca G, Cavalli G, Campochiaro C, Della-Torre E, Angelillo P, Tomelleri A, Boffini N, Tentori S, Mette F, Farina N, Rovere-Querini P, Ruggeri A, D'Aliberti T, Scarpellini P, Landoni G, De Cobelli F, Paolini JF, Zangrillo A, Tresoldi M, Trapnell BC, Ciceri F, Dagna L |display-authors=6 |title=GM-CSF blockade with mavrilimumab in severe COVID-19 pneumonia and systemic hyperinflammation: a single-centre, prospective cohort study |url= |journal=The Lancet Rheumatology |date=16 June 2020 |volume=2 |issue=8 |pages=e465–e473 |doi=10.1016/S2665-9913(20)30170-3 |pmid=32835256 |pmc=7430344 |doi-access=free}}

In April 2021, Kiniksa outlined the next steps for development of Mavrilimumab - including in COVID-19–related acute respiratory distress syndrome (ARDS), giant cell arteritis (GCA), and rheumatoid arthritis (RA). “Recent favorable interactions with the FDA, based upon the clinical data generated with mavrilimumab in COVID-19-related ARDS, giant cell arteritis, and rheumatoid arthritis, underscore the broad utility of mavrilimumab and define a regulatory pathway for Phase 3 clinical development for each indication,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We believe the ongoing Phase 3 study of mavrilimumab in COVID-19-related ARDS represents the fastest path to potential registration for the asset, and there remains a significant unmet need in these patients. Enrollment in our Phase 3 clinical trial is ongoing, and we expect data in the first quarter of 2022.”.{{Cite web|url=https://investors.kiniksa.com/news-releases/news-release-details/kiniksa-outlines-next-steps-development-mavrilimumab|title=Kiniksa Outlines Next Steps for the Development of Mavrilimumab | Kiniksa Pharmaceuticals}}