Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox

IndustryPRwire -- Chimerix announced that 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).

Brincidofovir, an investigational therapy, is a nucleotide analog lipid-conjugate that has demonstrated antiviral activity as a medical countermeasure against smallpox under the FDA’s Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans.

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.

Mike Sherman, Chief Executive Officer of Chimerix Commented “Our team has continued to execute extremely well in collaboration with BARDA to advance this program, As we’ve observed in recent months, the threat of serious viral infections requires robust pandemic plans to protect the population and our economy. With BCV, we hope to provide that protection from smallpox, and look forward to working with BARDA on next steps in making this countermeasure available to patients in advance of an outbreak.”

Source: Chimerix, Inc.

Related Posts

Subscribe Our Newsletter