U.S. Purchasing $290 MM in “Nuclear Emergency” Drugs

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The U.S. Department of Health and Human Services is purchasing a supply of the drug “Nplate” from Amgen USA Inc. Nplate is approved to treat blood cell injuries that accompany Acute Radiation Syndrome (ARS) in adult and pediatric patients (ARS).

Amgen, based in Thousands Oaks, California, developed Nplate for ARS with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), as well as the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

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. Amgen will maintain this supply in vendor-managed inventory. 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.

ARS, also known as radiation sickness, occurs when a person’s entire body is exposed to a high dose of penetrating radiation, reaching internal organs in a matter of seconds. Symptoms of ARS injuries include impaired blood clotting as a result of low platelet counts, which can lead to uncontrolled and life-threatening bleeding.

To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children.

Nplate is also approved for adult and pediatric patients with immune thrombocytopenia, a blood disorder resulting in low platelet counts. 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.

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.

Amgen will maintain this supply in vendor-managed inventory.

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.‘

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