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
Price :
$35
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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).