Overview of the regulatory approval of tecovirimat intravenous formulation for treatment of smallpox: potential impact on smallpox outbreak response capabilities, and future tecovirimat development potential.

ABSTRACT:

Introduction

Tecovirimat oral capsule formulation is approved in the US and Canada for treatment of smallpox and in the United Kingdom (UK) and European Union (EU) for treatment of multiple human orthopoxvirus diseases, including mpox. Smallpox is considered a serious threat, and there is currently an unprecedented global mpox outbreak.

Areas covered

A brief summary of the threat of smallpox, the threat of increasing mpox spread in endemic regions, and the unprecedented emergence of mpox into non-endemic regions is presented. The tecovirimat intravenous formulation clinical development program leading to USFDA approval for smallpox treatment is discussed.

Expert opinion

As of January 2023 tecovirimat is approved to treat mpox in the UK and EU. However, published clini

SUBMITTER: Russo AT 

PROVIDER: S-EPMC10054055 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature