The FDA has granted Orphan Drug Designation (ODD) to is product, brincidofovir, for the treatment of smallpox, a serious, and often deadly infectious disease.
This morning, Chimerix announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to is product, brincidofovir, for the treatment of smallpox, a serious, and often deadly infectious disease.
“We are very pleased to have received Orphan Drug Designation from the FDA for brincidofovir as a treatment for smallpox,” Chimerix’s president and chief executive officer M Michelle Berrey, MD, MPH, said in a recent statement. “Though declared eradicated in the late 1970s, smallpox, whether natural of synthetic, continues to be a potential global threat in today’s interconnected world.”
Brincidofovir (CMX001) has demonstrated an improvement in survival rates following orthopoxvirus infections in several animal models.
In order to develop the experimental antiviral drug as a medical countermeasure to treat the disease and any potential outbreaks that may spring up due to a bioterror event or even accidental release, Chimerix has been working closely with the Biomedical Advanced Research and Development Authority since 2011. While 1949 recorded the last natural outbreak of virus, the melting Siberian tundra continues to increase the chances of smallpox making a comeback.
The melting tundra rings alarms from experts since they claim the thawed corpses of those who died during the epidemic over 120 years ago may resurface, resulting in a revived outbreak. Rerason for concern is only validated by a team of researchers in Canada who successfully synthesized the horsepox virus, which is a close relative of smallpox. Additional experts in the field warned against the risky nature of experiments of this nature, which could be the possible opening of Pandora’s box when it comes to deadly diseases.
Previously, the FDA accepted SIGA Technologies, Inc’s New Drug Application for an oral formulation of a smallpox medication called tecovirimat (TPOXX), a novel small molecule antiviral therapy preceding this ODD. In addition, the FDA granted priority review to the application, with the target final action date anticipated to be in August 8, 2018.
“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,” Dr Berrey said.