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. 2023 Mar;21(3):235-242.
doi: 10.1080/14787210.2023.2170350. Epub 2023 Feb 2.

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

Andrew T Russo  1 , Douglas W Grosenbach  1 , Kady M Honeychurch  1 , Paul G Long  1 , Dennis E Hruby  1
Affiliations

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

Andrew T Russo et al. Expert Rev Anti Infect Ther. 2023 Mar.

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 clinical trial data evaluating tecovirimat efficacy and safety in mpox patients is pending. Increasing global prevalence of mpox highlights the potential benefits of a well-characterized, effective, and safe antiviral treatment for mpox infection. Ongoing trials in mpox patients may provide results supporting the use of tecovirimat to treat this disease. USFDA approval of tecovirimat for post-exposure prophylaxis in the event of a smallpox release, and the development of pediatric liquid formulations for patients under 13 kg, could provide additional public health benefits.

Keywords: ST-246; TPOXX®; antiviral; biodefense; intravenous formulation; monkeypox virus; mpox; smallpox; tecovirimat.

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Conflict of interest statement

Declaration of interest

AT Russo is a current employee of SIGA Technologies, Inc. and may hold stock or equity interests in the company. DW Grosenbach is a current employee of SIGA Technologies, Inc. and may hold stock or equity interests in the company. KM Honeychurch is a current employee of SIGA Technologies, Inc. and may hold stock or equity interests in the company. PG Long is a current employee of SIGA Technologies, Inc. and may hold stock or equity interests in the company. DE Hruby is a current employee of SIGA Technologies, Inc. and may hold stock or equity interests in the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in the manuscript.

References

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