The Food and Drug Administration (FDA) has accepted for filing and review Biologics License Application (BLA) for Anthim (obiltoxaximab), a new drug to treat and prevent inhalational anthrax, a top bioterror threat.
Anthim is a candidate for future acquisition into the Strategic National Stockpile, the US government’s repository of critical medical supplies for biowarfare preparedness. Anthim has been developed under fast-track status and Orphan Drug Designation by the FDA.
This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS).
"FDA acceptance of our BLA submission is an important milestone toward our goal of supplying Anthim for the Strategic National Stockpile to help protect the U.S. public from the potential deadly bioterror threat of anthrax," said Elusys President and CEO Dr. Elizabeth Posillico. “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.”
“Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation’s top biowarfare threats,” Elusys said in a statement. “Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics. In the 2001 anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 50 percent in humans infected, even when victims were given antibiotics and supportive hospital care. Under current guidelines, CDC recommends the use of anthrax antitoxins with antibiotics in cases where there is a high level of clinical suspicion for systemic anthrax.
The FDA’s filing acceptance is based on submission of efficacy data studied in animal models of inhalational anthrax and safety data from 350 healthy human volunteers receiving the proposed human therapeutic dose of Anthim administered intravenously. Efficacy and safety data obtained on intramuscular administration of Anthim were also included in the application. The more common treatment emergent adverse events occurring in clinical trials of Anthim administered by IV infusion compared to placebo included headache, pruritus, cough urticaria and rash.
Anthim is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax and is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and intramuscular (IM) prophylaxis administration.
IV administration is being evaluated for the treatment of patients who have established infection and are symptomatic for anthrax disease, as well as for prophylaxis. Prophylaxis includes immediate pre-exposure prophylaxis (as in the case of emergency personnel responding to an event) and post-exposure prophylaxis (when there is reason to believe a person may have been exposed to anthrax but prior to signs/symptoms of infection).
The ability to administer an anti-toxin via IM injection may provide a valuable alternative to IV injection in an emergency where medical resources and personnel may be limited or when IV administration is not feasible.