Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak

Ofole Mgbako; Justin Chan; Robert A. Pitts; Madeline A. DiLorenzo; Dorothy Knutsen; Dana Mazo

doi:10.1017/ash.2023.194

Antimicrobial Stewardship & Healthcare Epidemiology (Jan 2023)

Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak

Ofole Mgbako,
Justin Chan,
Robert A. Pitts,
Madeline A. DiLorenzo,
Dorothy Knutsen,
Dana Mazo

Affiliations

Ofole Mgbako: ORCiD; Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA
Justin Chan: Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA
Robert A. Pitts: Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA
Madeline A. DiLorenzo: ORCiD; Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA
Dorothy Knutsen: Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA
Dana Mazo: Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA

DOI: https://doi.org/10.1017/ash.2023.194
Journal volume & issue: Vol. 3

Abstract

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During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND’s regulatory requirements and rapidly provide tecovirimat to patients.

Published in Antimicrobial Stewardship & Healthcare Epidemiology

ISSN: 2732-494X (Online)
Publisher: Cambridge University Press
Country of publisher: United Kingdom
LCC subjects: Medicine: Internal medicine: Infectious and parasitic diseases; Medicine: Public aspects of medicine
Website: https://www.cambridge.org/core/journals/antimicrobial-stewardship-and-healthcare-epidemiology

About the journal