Responding to requests from treating physicians, FDA has okayed brincidofovir for Emergency Investigational New Drug Applications (EIND), allowing it to be used in the treatment of the Ebola virus disease.
Responding to requests from treating physicians, FDA has okayed brincidofovir for Emergency Investigational New Drug Applications (EIND), allowing it to be used in the treatment of the Ebola Virus Disease.
The drug, developed by biopharmaceutical company Chimerix, Inc, was being used to treat Thomas Duncan, the Liberian national who died at a Dallas hospital, where he was in isolation. Duncan became ill with the virus after entering the United States on September 20.
"Chimerix is committed to working with global health organizations and government agencies in the fight against the Ebola virus outbreak," said M. Michelle Berrey, MD, MPH, president and chief executive officer of Chimerix.
"Based on in vitro data from work conducted by the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) suggesting brincidofovir's activity against Ebola, we are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak.”
There are currently no FDA approved vaccines for Ebola, according to the CDC, but the NIH’s National Institute of Allergy and Infectious Diseases is working on developing an Ebola vaccine. Another drug, ZMapp, being developed by Mapp Biopharmaceutical Inc., is undergoing testing as a therapeutic product but has not yet been tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus, according to the CDC.
Data on brincidofovir collected over years of clinical development provided information on the safety and dosing of the drug to allow it to be explored as a potential therapy for Ebola Virus Disease, said the company.
FDA is now working to finalize a clinical trial protocol with brincidofovir which will assess the safety, tolerability, and efficacy of the drug in Ebola patients.
Previous test tube assessments of the drug revealed activity against other viral diseases including adenovirus and smallpox. Test tube assessments against the Ebola virus revealed similar activity.
Chimerix also reported that animal model tests of brincidofovir against the Ebola virus infection are currently underway.
"Obviously, this is extremely important as any potential treatment for this deadly virus would save many lives," according to FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, University of Missouri-Kansas City. "It will take some time to sort through the data to assess efficacy of a product like this. My guess is that there several other pharmaceutical companies that may also bring products to market for evaluation."