These studies showed survival benefit in two relevant animal species, which is the minimum requirement for establishing the efficacy of new drugs used in countering bioterrorism.
Raxibacumab is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services (HHS).
Sally D. Bolmer, Senior Vice President, Development and Regulatory Affairs, HGS, said: “Based on the results of our efficacy and safety studies, we believe raxibacumab has the potential to be an important new treatment for inhalation anthrax. In addition, the raxibacumab BLA is the first HGS has submitted, so it represents a significant milestone for our company.”