FDA grants approval for anthrax treatment
BLA acceptance allows the treatment to be provided to national stockpiles and to be available on the market should a case appear in the U.S. They were granted approval based on positive results in both animal models for efficacy and human volunteer tests that proved that the compound is safe.
"Anthim has been developed under two contracts with the Biological Advanced Research and Development Authority (BARDA), and we look forward to continuing to work with BARDA in the interest of our nation's security," Elusys Therapeutics' President and CEO Elizabeth Posillico said.
Anthim is an antibody that has been in development to act as a preventive measure and treatment option for inhaled forms of the anthrax bacteria. According to the company, it is the sole treatment of its kind to be in the late stages of investigation into intravenous and intramuscular administration.
Anthrax is considered a Category A pathogen in terms of biological terrorism threats. Inhaled forms are highly lethal and were used as part of a mail-based attack that infected 22 people, including mail carriers, in 2001.