Health
FDA approves Tpoxx IV formulation for smallpox
The Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Tpoxx.® (Tecovirimat) For the treatment of human smallpox disease caused by smallpox virus in adult and pediatric patients.
Previously, Tpoxx was only offered as: Oral capsule.. The IV formulation is designed to provide an alternative option for patients who cannot swallow oral capsules.
Tpoxx functions by targeting and inhibiting the activity of the orthopoxvirus VP37 protein and blocking the interaction of cells with Rab9 GTPase and TIP47. This prevents the formation of enveloped virions with the exit capacity required for intercellular and long-distance spread of the virus. The FDA has approved Tpoxx based on the results of a well-managed animal efficacy study of non-human primates and rabbits infected with the non-variola orthopox virus.
“We thank the FDA for its efforts to approve IVTpoxx to provide access to a wider patient population,” said Dr Dennis Hruby, CSO of SIGA. “We also thank our BARDA colleagues for working with us for many years to include oral and IV Tpoxx in US preparatory activities and continue to work with them on our liquid pediatric formulations. looking forward to it.”
Not approved in the United States, but Tpoxx has been shown to treat Monkeypox In Europe. According to SIGA, Tpoxx’s IV formulation was cited in the Biden administration’s recent budget request to treat patients in the United States with monkeypox.
References
- SIGA has been approved by the FDA for an intravenous (IV) formulation of Tpoxx® (tecovirimat). news release. SIGA Technologies, Inc. Accessed May 19, 2022. https://www.globenewswire.com/news-release/2022/05/19/2446804/9738/en/SIGA-Receives-Approval-from-the-FDA-for-Intravenous-IV-Formulation-of-TPOXX- tecovirimat.html
- A new contract awarded by the US Department of Defense to raise up to approximately $ 7.5 million in oral Tpoxx®. news release. SIGA Technologies, Inc. May 12, 2022. Accessed on May 19, 2022. https://investor.siga.com/news-releases/news-release-details/new-contract-awarded-us-department-defense-procurement
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