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The Challenges Ahead With Monoclonal AntibodiesFrom Authorization to Access

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To identify the key insights or developments described in this article

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JAMA

Published Online: November 11, 2020

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Article Information and Disclosures

Robert H. Goldstein, MD, PhD^1,3;

Rochelle P. Walensky, MD, MPH^2,3

Author Affiliations

¹Division of Infectious Diseases and Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston
²Division of Infectious Diseases, Massachusetts General Hospital, Boston
³Harvard Medical School, Boston, Massachusetts

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When President Trump received an infusion of a monoclonal antibody cocktail (REGN-COV2 from Regeneron) on October 2, 2020, his physicians were presumably reacting to promising data reported in the company’s news release from 3 days earlier. The company had announced the results of a trial involving 275 individuals randomized 1:1:1 to placebo, low-dose monoclonal antibody treatment, or high-dose treatment.¹ Per the news release, those patients with high viral loads and those who had not already mounted their own antibody response showed a greater decrease in viral load and time to resolution of symptoms. Additional data on more important outcomes, including rates of hospitalization, development of serious illness, and mortality were not available. It was not clear, although unlikely, if the study was powered to detect these outcomes.

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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

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

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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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

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

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.2020.8863 PubMed Google Scholar

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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

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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Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.