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The Challenges Ahead With Monoclonal AntibodiesFrom Authorization to Access

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Article Information

Corresponding Author: Robert H. Goldstein, MD, PhD, Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit St, Cox 5, Boston, MA 02114 (rgoldstein3@partners.org).

Published Online: November 11, 2020. doi:10.1001/jama.2020.21872

Conflict of Interest Disclosures: None reported.

References
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Regeneron’s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients. News release. Regeneron; September 29, 2020. Accessed October 17, 2020. https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and
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Woolf  SH , Chapman  DA , Sabo  RT , Weinberger  DM , Hill  L , Taylor  DDH . Excess deaths from COVID-19 and other causes, March-July 2020. JAMA. Published online October 12, 2020.
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WHO Solidarity Trial Consortium.  Repurposed antiviral drugs for COVID-19—interim WHO SOLIDARITY trial results.   medRXiv. Preprint posted October 15, 2020. doi:10.1101/2020.10.15.20209817Google Scholar
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Spinner  CD , Gottlieb  RL , Criner  GJ ,  et al.  GS-US-540-5774 Investigators. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial.   JAMA. 2020;324(11):1048-1057. doi:10.1001/jama.2020.16349PubMedGoogle ScholarCrossref
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Gilead announces results from phase 3 trial of investigational antiviral remdesivir in patients with severe COVID-19. News release. Gilead Sciences Inc; April 29, 2020. Accessed October 17, 2020. https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19
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Biegel  JH , Tomashek  KM , Dodd  LE ,  et al. Remdesivir for the treatment of COVID-19—final report. N Engl J Med. First published online May 22, 2020. Updated online October 8, 2020. doi:10.1056/NEJMoa2007764
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Ison  MG , Wolfe  C , Boucher  HW .  Emergency Use Authorization of remdesivir: the need for a transparent distribution process.   JAMA. 2020;323(23):2365-2366. doi:10.1001/jama.2020.8863PubMedGoogle Scholar
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Sarpatwari  A , Kaltenboeck  A , Kesselheim  AS .  Missed opportunities on emergency remdesivir use.   JAMA. 2020;324(4):331-332. doi:10.1001/jama.2020.11932PubMedGoogle ScholarCrossref
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Walker  J , Loftus  P . Antibody drugs touted by Trump could be next to get authorized for COVID-19. Wall Street Journal. October 9, 2020. Accessed October 17, 2020. https://www.wsj.com/articles/antibody-drugs-touted-by-trump-could-be-next-to-get-authorized-for-covid-19-11602235803
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Lee  J . SVP Leerink analysts predict $1 billion in peak sales of Regeneron’s experimental COVID-19 treatment. MarketWatch. Published October 6, 2020. Accessed October 17, 2020. https://www.marketwatch.com/story/svb-leerink-analysts-predict-1-billion-in-peak-sales-of-regenerons-experimental-covid-19-treatment-2020-10-06
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