April 28, 2020: “Chimerix, a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases announced that the Company has received clearance from the U.S.FDA for a rolling submission of its NDA for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox.
The Company intends to begin the rolling NDA submission for BCV in May 2020 with completion targeted for mid-2020.
Chimerix is developing 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 USG Contract No HHSO10201100013C.
“The value of being prepared for viral outbreaks has never been clearer. The potential for engineered or naturally occurring resistance to the currently approved therapy has made the development of BCV imperative,” stated Mike Sherman, Chief Executive Officer of Chimerix.
“The clearance to begin the rolling submission of the NDA for BCV is an important milestone for both the company and BARDA as it brings us one step closer to realizing the mandate of Project Bioshield.
Our NDA preparation is already in process and we look forward to working with BARDA on a potential procurement contract in advance of FDA approval.”
In a lethal model, BCV when administered at varying times post-infection demonstrated a statistically significant survival advantage relative to placebo.
This observation was consistent throughout all time points.”
