The U.S. Department of Health and Human Services (HHS) is buying $290 million worth of drugs as part of its “long-standing, ongoing efforts to be better prepared to save lives following radiological and nuclear emergencies.”
HHS is purchasing a supply of the drug Nplate from Amgen USA, a biotechnology headquartered in Thousand Oaks, California.
Nplate is the trade name of romiplostim, which was approved by the U.S. Food and Drug Administration (FDA) in January 2021 to treat blood cell injuries that accompany acute radiation syndrome (ARS) in adults and children.
ARS is also referred to as radiation sickness, which reaches internal organs in mere seconds and “occurs when a person’s entire body is exposed to a high dose of penetrating radiation.” It can result in a difficulty for blood to clot because of low platelet counts, which can lead to uncontrolled bleeding, which is life-threatening.
Nplate helps reduce the radiation-induced bleeding by stimulating the body to produce more platelets.
According to the announcement, Amgen’s development of Nplate for radiation sickness was supported by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). BARDA is part of the HHS ASPR, and NIAID is part of the National Institutes of Health (NIH).
“BARDA is using its authority provided under the 2004 Project Bioshield Act and $290 million in Project BioShield designated funding to purchase this supply of the drug,” the ASPR announcement reads.
“Amgen will maintain this supply in vendor-managed inventory,” ASPR said of the Nplate drug supply. “This approach decreases life-cycle management costs for taxpayers because doses that near expiration can be rotated into the commercial market for rapid use prior to expiry and new doses can be added to the government supply.”
“The FDA’s decision was based largely on NIAID-supported studies showing that romiplostim greatly increases survival in an animal model of radiation exposure,” NIAID stated at the time.
“Repurposing drugs for acute radiation syndrome that also are approved for a commercial indication helps to sustain availability of the product and improves healthcare provider familiarity with the drug,” ASPR announced on Oct. 4.