The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) this week announced it will add two types of anthrax antitoxin drugs to 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.”
Elusys Therapeutics – Anthim
A 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 is a high-affinity monoclonal antibody (mAb) 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. 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.
GlaxoSmithKline – Raxibacumab
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.
Source: HHS, adapted.