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An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

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Trial Profile

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

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At a glance

  • Drugs Tecovirimat (Primary)
  • Indications Orthopoxvirus infections; Smallpox
  • Focus Adverse reactions; Registrational
  • Sponsors SIGA Technologies

    • Most Recent Events

    • 10 Jan 2022 According to a SIGA Technologies media release, the company announced that the European Medicines Agency (EMA) approved oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.
    • 16 Nov 2021 According to a SIGA Technologies media release, The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein. company is targeting EMA approval for the first quarter of 2022.
    • 16 Nov 2021 According to a SIGA Technologies media release, European Medicines Agency Committee for Medicinal Products for Human Use published their summary opinion in support of approval of Marketing Authorisation Application for oral tecovirimat. The recommendation from the CHMP, which plays a vital role in conducting the scientific assessment of MAAs, included support for broader labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications.
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