(Released 6 Ocotber 2016)As a part of its mission to help protect Americans’ health following even the most unthinkable of disasters, the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is purchasing two medical products to treat injuries to bone marrow in victims of radiological or nuclear incidents. Bone marrow is essential to producing blood.
The two products, called colony stimulating factors, stimulate bone marrow to produce blood cells including neutrophils that reduce the body’s risk of developing an infection and decrease risk of death from acute radiation syndrome. Infections often occur after exposure to high doses of radiation. These types of products are used commonly to reduce the risk of infection in patients with cancer.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is purchasing the first of these two leukocyte growth factor products, called Neulasta, from Amgen USA, Inc. of Thousand Oaks, California, under an approximately $37.7 million agreement. BARDA will purchase the second product, called Leukine, from Sanofi-Aventis U.S., LLC of Bridgewater, New Jersey, under a $37.6 million agreement. Sanofi-Aventis is a subsidiary of Sanofi.
Neulasta is approved by the U.S. Food and Drug Administration (FDA) to treat adults and children exposed to high levels of radiation that damage bone marrow. BARDA continues to work with Sanofi-Aventis to support the studies needed to request FDA approval of Leukine.
BARDA will purchase both products using funding and authority provided through the Project BioShield Act of 2004. Under the Project BioShield Act, the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats.
The products add to the available treatment options in the Strategic National Stockpile for acute radiation syndrome. Previously, BARDA sponsored advanced development and purchased another leukocyte growth factor product called Neupogen, which is now also FDA-approved for use in treating adults and children exposed to levels of radiation that damage the bone marrow.
Today’s purchase of Neulasta and Leukine increases the number of colony stimulating factor doses available for use in an emergency response. It also increases operational capability since treatments with Neulasta are given once weekly, whereas treatment with Neupogen are given daily. With the purchase of Neulasta and Leukine, BARDA now has supported the advanced development of or purchased 17 medical countermeasures using Project BioShield Act funding and authority. These products include treatments for some of the health effects of ionizing (damaging) radiation, exposure to chemical agents, burns injuries, as well as products to prevent or treat illness from anthrax, smallpox, or botulism.
This work is part of BARDA’s comprehensive, integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to radiological and nuclear agents, these threats include chemical and biological terrorism threats, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. Contract opportunities are announced at www.fbo.gov.
HHS Press Office