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

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

Antimicrob Steward Healthc Epidemiol. 2023 Jun 29;3(1):e110. doi: 10.1017/ash.2023.194. eCollection 2023.

Authors

Ofole Mgbako^{1

2}, Justin Chan^{1

2}, Robert A Pitts^{1

2}, Madeline A DiLorenzo¹, Dorothy Knutsen^{1

2}, Dana Mazo¹

Affiliations

¹ Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA.
² Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA.

Abstract

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.

Publication types

Editorial