On October 4, the U.S. Department of Health and Human Services (HHS) announced that it was purchasing roprostim from Amgen to respond to radiological and nuclear emergencies.
Roprostim (Nplate) is a second-generation long-acting thrombopoietin (TPO) receptor agonist that stimulates platelet production by mimicking the body’s natural TPO. Nplate has been approved for the treatment of immune thrombocytopenia (ITP) in China and the United States, and has also been selected as the “Best Biotechnology Product” by the Galen Award, known as the “Nobel Prize in Medicine”.
In 2021, Nplate received an FDA-expanded indication to improve survival in adult and pediatric patients (including term neonates) who are acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). That is, Nplate stimulates platelet production in patients, thereby reducing radiation-induced bleeding.
The new indication for Nplate was developed by Amgen with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Strategic Preparedness and Response Authority (ASPR). BARDA is following the provisions of the Biological Shield Program Act of 2004 and using the $290 million designated by the Act to purchase the supply of Nplate.
Acute Radiation Syndrome (ARS), also known as radiation poisoning or radiation sickness, is a series of acute symptoms that occurs when a patient’s entire body is exposed to high doses of penetrating radiation that penetrates internal organs within seconds . Symptoms of ARS loss include coagulation dysfunction due to low platelet counts, which can further lead to uncontrolled, life-threatening bleeding.