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lunes, 23 de abril de 2018
HHS purchases anthrax antitoxin for Strategic National Stockpile
Acquisition augments anthrax treatments currently stockpiled
The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR ) will purchase an anthrax treatment for $25.2 million from Elusys Therapeutics Inc. of Pine Brook, New Jersey, as part of the department’s ongoing national preparedness efforts.
“Protecting the American people from 21st century threats, such as anthrax, remains a high priority for the department,” said Dr. Robert Kadlec, assistant secretary for preparedness and response. “This procurement under Project BioShield ensures we continue to have treatment options for people exposed to anthrax and increases the number of courses available in an emergency.”
The Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, provided funding under Project BioShield for continued manufacturing and purchase of the treatment called Anthim or obiltoxaximab. The product will be delivered to the Strategic National Stockpile, the nation’s largest supply of potentially life-saving medical countermeasures, such as vaccines, therapeutics and diagnostics, for use in a public health emergency.
Anthim is an antibody-based therapeutic that can complement antibiotics by neutralizing the toxins produced by Bacillus anthracis, the bacteria that cause anthrax disease. The treatment was developed through a public-private partnership with Elusys and BARDA after early research funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
In March 2016, the U.S. Food and Drug Administration approved Anthim for use in patients suffering from inhalational anthrax. BARDA used Project BioShield to fund the first delivery of Anthim to the Strategic National Stockpile in 2016. Project BioShield funds are used to purchase critical medical countermeasures, which often have no commercial market and are needed to protect against national security threats.
HHS’ comprehensive approach to meet immediate public health needs in an anthrax attack includes the acquisition of vaccines, antibiotics and therapeutics. While antibiotics can be effective in treating bacteria like anthrax, antibody-based therapeutics treat the toxins released by the anthrax bacteria that lead to illness and death.
The purchase is part of BARDA’s 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 that threaten the U.S. civilian population. BARDA is seeking to develop additional medical countermeasures and accepts proposals through the Broad Agency Announcement “BARDA-BAA-18-100-SOL-00003” at https://www.fbo.gov.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st century health security threats. To learn more, visit www.phe.gov and www.medicalcountermeasures.gov.
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