Under the Project BioShield Act, the U.S. BARDA continues to work with Sanofi-Aventis to support the studies needed to request FDA approval of Leukine.īARDA will purchase both products using funding and authority provided through the Project BioShield Act of 2004. Food and Drug Administration (FDA) to treat adults and children exposed to high levels of radiation that damage bone marrow. Sanofi-Aventis is a subsidiary of Sanofi. BARDA will purchase the second product, called Leukine, from Sanofi-Aventis U.S., LLC of Bridgewater, New Jersey, under a $37.6 million agreement. of Thousand Oaks, California, under an approximately $37.7 million agreement. These types of products are used commonly to reduce the risk of infection in patients with cancer.ĪSPR’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.
Infections often occur after exposure to high doses of radiation. 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.
Bone marrow is essential to producing blood. 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.
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