FDA approves Nplate for acute radiation syndrome

Leading Research to Understand, Treat, and Prevent Infectious, Immunologic, and Allergic Diseases          Visit us on the Web The Radiation and Nuclear Countermeasures Program (RNCP) is pleased to announce that on Thursday, January 28, 2021, the FDA approved the Supplemental Biologics License Application (sBLA) application from Amgen for Nplate, to add the following indication to the package insert: "Patients with Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS):  Nplate is indicated to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation." The RNCP, along with colleagues from the Division of Allergy, Immunology, and Transplantation (DAIT) Office of Regulatory Affairs and Clinical Research Operations Program, is tremendously proud to have been involved in this regulatory approval. More information is in the bullets below: In the case of a radiological or nuclear public health emergency, many thousands of people could experience severe injuries from radiation exposure, resulting in immunosuppression and infection, hemorrhage, major morbidities, and even death. Studies sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) demonstrated that administration of Nplate (Amgen), originally licensed in 2008 for treatment of immune thrombocytopenia, increased platelet counts and improved survival in preclinical models of lethal radiation exposure.  With the January 28, 2021, approval of Nplate for hematopoietic acute radiation syndrome (H-ARS), the FDA has now granted approvals for four products to treat H-ARS, three of which relied on NIAID-supported preclinical data.  The FDA Animal Rule approval of Nplate is the result of a collaboration between NIAID, the Biomedical Advanced Research and Development Authority (BARDA), and Amgen, with NIAID sponsoring the pivotal studies that were the basis for the approval.  Nplate represents a new class of molecules to target radiation-induced hemorrhage by increasing platelet counts. The survival benefit of Nplate appears to be additive to that of existing approved products, providing an extra dimension to the treatment of H-ARS.   The approved labeling has been posted on the FDA site (FDA PDF). Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com. This service is provided to you at no charge by National Institute of Allergy and Infectious Diseases (NIAID). This email was sent to myhcistech.healthnews360@blogger.com using GovDelivery Communications Cloud on behalf of: National Institute of Allergy and Infectious Diseases · 5601 Fishers Lane · Bethesda, MD 20892 · 1-866-284-4107