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A Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients

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Trial Profile

A Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2021

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At a glance

  • Drugs Brincidofovir (Primary)
  • Indications Cytomegalovirus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SUPPRESS
  • Sponsors Chimerix
  • Most Recent Events

    • 05 Aug 2021 According to a Chimerix media release, the company has received approval for TEMBEXA tablets and oral suspension (adult and pediatric patients) from U.S. Food and Drug Administration (FDA) for the treatment of smallpox.
    • 25 Feb 2021 According to a Chimerix media release, the company has received notification from the FDA that the Prescription Drug User Fee Act (PDUFA) goal date for review of brincidofovir (BCV) as a medical countermeasure for smallpox has been extended three months to July 7, 2021. FDA requested we provide data supporting a dose recommendation for infants up to three months of age, it was submitted later.
    • 07 Dec 2020 According to a Chimerix media release, the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox. The FDA granted Priority Review and set an action date of April 7, 2021 under the Prescription Drug User Fee Act (PDUFA).
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