FDA Grant Orphan Drug Status to Brincidofovir for Smallpox
The Food and Drug Administration (FDA) has granted Orphan Drug Designation to brincidofovir (Chimerix) for the treatment of smallpox.
Brincidofovir is a nucleotide analog that has antiviral activity against variola virus, which causes smallpox. The treatment has previously been granted Fast Track status for the treatment of adenovirus and smallpox, and for the prevention of cytomegalovirus.
Since 2011, the Company has worked with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir for treating smallpox. "Though declared eradicated in the late 1970s, smallpox, whether natural or synthetic, continues to be a potential global threat in today's interconnected world," said M. Michelle Berrey, MD, MPH, CEO and President of Chimerix.
The Company stated that they will continue to work closely with BARDA and the FDA to complete the development program.
For more information visit Chimerix.com.