Chimerix announces FDA acceptance of an NDA for brincidofovir as a medical countermeasure for smallpox.

Chimerix announced that the 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). Chimerix has developed BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under ongoing contract number HHSO100201100013C. The FDA's acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review. A Priority Review designation accelerates the FDA's review time from 10 months to a goal of six months and is granted to drugs that may offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. At this time, the FDA is not planning to hold an advisory committee meeting to discuss this application.