Chimerix gets emergency FDA approval for Ebola antiviral

DURHAM, N.C. — Biopharmaceutical company Chimerix on Monday announced that brincidofovir has been provided for potential use in patients with Ebola virus at the request of treating physicians. Emergency investigational new drug applications were granted by the Food and Drug Administration.

 

"Chimerix is committed to working with global health organizations and government agencies in the fight against the Ebola virus outbreak," said M. Michelle Berrey, M.D., M.P.H., president and CEO of Chimerix. "Based on in vitro data from work conducted by the CDC and the National Institutes of Health suggesting brincidofovir's activity against Ebola, we are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak. Data collected over years of clinical development of brincidofovir have allowed us to progress this compound into Phase 3 programs for cytomegalovirus and adenovirus infections, and provided information on the safety and dosing of brincidofovir to allow it to be explored as a potential therapy for Ebola Virus Disease."

 

The company said it is working with the FDA to finalize clinical trial protocol this week to assess the safety and efficacy of the drug in patients who are confirmed to have Ebola.