To better protect public health in an anthrax attack, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will add two types of anthrax antitoxin drugs for the Strategic National Stockpile (SNS) as options to treat inhalational anthrax.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will fund these purchases under Project BioShield, the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect the American public against chemical, biological, radiological and nuclear threats.
“Anthrax remains a bioterrorist threat, and the actions we are taking today will help protect our nation against that threat,” said Robin Robinson, Ph.D., Director of BARDA. “By expanding the treatment options available within the SNS, we can help meet the diverse needs of the American people in an anthrax-related emergency.”
Through today’s five-year, $44.9 million agreement with Elusys Therapeutics of Pine Brook, New Jersey, BARDA will support production and future delivery of Elusys’ anthrax antitoxin drug Anthim to the SNS. Anthim is a monoclonal antibody that binds to a key bacterial protein and reduces anthrax’s toxic effects. The antitoxin becomes the fourteenth product to be added to the SNS under Project BioShield since 2004.
Support for development of Anthim transitioned from early development with the National Institute of Allergy and Infectious Diseases (NIAID) to advanced development with BARDA in 2009. NIAID, BARDA and other federal partners plan out such transitions to ensure new medical products critical to our national security are made available as quickly and cost-efficiently as possible. These agencies coordinate and prioritize federal medical countermeasure efforts through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).
Elusys submitted a Biologics License Application for Anthim to the U.S. Food and Drug Administration (FDA) in March 2015, and BARDA continues to support the drug’s development under a separate research and development contract. Prior to licensure, large-scale use of Anthim after an anthrax attack would require Emergency Use Authorization from FDA.
In addition, through a continuing agreement with GlaxoSmithKline BARDA will fund the production and delivery of the anthrax antitoxin drug Raxibacumab to replace expiring doses in the SNS.
Raxibacumab is also a monoclonal antibody therapeutic to treat illness caused by anthrax. BARDA has funded advanced development and procurement of the drug under Project Bioshield since 2009 and in 2012 Raxibacumab became the first anthrax antitoxin to be approved by the FDA. Now, BARDA will provide $9.7 million to ensure a continued supply of Raxibacumab to the SNS through 2019.
The Secretary of Homeland Security determined anthrax to be a material threat to nation security in 2004. To prepare for these chemical, biological, radiological or nuclear threats, BARDA and other federal agencies collaborate and prioritize through the Public Health Medical Countermeasure Enterprise to develop drugs, vaccines, diagnostics and devices, and BARDA purchases the products for the SNS.
In addition to augmenting the current anthrax medical countermeasure holdings in the SNS, BARDA takes a comprehensive and integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergencies caused by chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases.