The deal was sanctioned by the US Department of Health and Human Services, which stated that the agreement was reached as part of a long-standing, ongoing effort to be “better prepared to save lives following radiological and nuclear emergencies.”
Amgen is tasked with supplying Nplate (romiplostim) and the treatment is approved for both adults and children that have blood cell injuries due to acute radiation syndrome.
The US Biomedical Advanced Research and Development Authority (BARDA) will provide the funds, $290m (€295m) in total, through the Project Bioshield Act.
According to the authority, Amgen will maintain this supply in a vendor-managed inventory. This will mean that doses close to expiry can be rotated into the commercial market for rapid use prior to expiry and new doses will then be added back into the government supply.
The announcement emerges as nuclear tensions reach their highest point in years, with the war in Ukraine leading to fears for the potential for the use of tactical nuclear weapons. President Biden recently stated that the risk of ‘nuclear Armageddon’ was its highest level since the Cuban Missile Crisis in the 1960s.
The Nplate treatment works by stimulating the body’s production of platelets, which counteracts the reduction in platelet count caused by radiation sickness. The treatment is also approved for patients with immune thrombocytopenia, a blood disorder that results in low platelet counts.
The treatment was developed by Amgen alongside support from the National Institute of Allergy and Infectious Diseases (NIAID). At the time of its first approval, NIAID also stated that the treatment could also be used should there be an accident at a nuclear reactor, a radiotherapy accident, or in the event of the escape of radioactive waste, not just in the situation of a nuclear attack.
NIAID stated that the treatment had been approved under the US Food and Drug Administration (FDA)’s Animal Rule, which allows a therapy to be approved on efficacy testing in animals and safety testing in humans. This is because it was not possible to create a clinical trial with participants showing symptoms of acute radiation syndrome.
Only a few days prior to the announcement of the purchase of Nplate, BARDA provided funds to Marinus Pharmaceuticals to provide US manufacturing capability for a treatment against nerve agents.