Chimerix Receives Orphan Drug Designation from the FDA for Brincidofovir for the Treatment of Smallpox
Chimerix announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for brincidofovir for the treatment of smallpox.
Chimerix has been working with the Biomedical Advanced Research and Development Authority (BARDA) since 2011 to develop brincidofovir as a medical countermeasure for smallpox, demonstrating improved survival rates following confirmed orthopoxvirus infections in multiple animal models.
“We are very pleased to have received Orphan Drug Designation from the FDA for brincidofovir as a treatment for smallpox,” said M. Michelle Berrey, MD, MPH, President and Chief Executive Officer of Chimerix. “Though declared eradicated in the late 1970s, smallpox, whether natural or synthetic, continues to be a potential global threat in today’s interconnected world. We are committed to completing the development program for brincidofovir as a much-needed treatment option for smallpox, in close collaboration with BARDA and FDA.”
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides manufacturers with many benefits, including a waiver of the FDA Prescription Drug User Fee Act.