Elusys Therapeutics, Inc. (Elusys) today announced the U.S. Food and Drug Administration (FDA) has accepted for filing and review its Biologics License Application (BLA) for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. 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.
"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 Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "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. 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% 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 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.
Elusys Therapeutics, Inc.