BARDA announces its 60th FDA Approval/Licensure/Clearance for Medical Countermeasures supported by BARDA under Novel Public Private Partnerships

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Since BARDA was established in 2006, its team of experts and scientists has collaborated with more than 300 industry partners to support development and manufacturing of a diverse portfolio of medical countermeasures needed to address national security and public health threats. Novel technologies, medicines, diagnostics and vaccines can save lives, protect the American people and enhance global health security.

The recent FDA approval of smallpox therapeutic TEMBEXA (brincidofovir), from partner Chimerix, Inc. signifies such a milestone in enhancing the Nation’s preparedness. TEMBEXA is an antiviral drug that inhibits activity of a critical viral enzyme, preventing the virus from replicating and causing disease. In February 2011, BARDA and Chimerix began collaborating and built on earlier work with other federal agencies to complete the activities - including advanced development and manufacturing of the therapeutic - required for the company to apply for FDA approval.

Dr. Karl Hostetler, a professor of medicine from the University of California, San Diego School of Medicine, discovered the drug brincidofovir (TEMBEXA) and advanced it through early development at Chimerix, which he founded. The product benefitted from the early support of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Despite the successful eradication of smallpox worldwide by 1980, the demonstration that poxviruses can be synthesized de novo provides evidence that smallpox remains a significant threat; re-emergence of the virus, whether naturally occurring or intentional, would be devastating for people around the globe. The approval of TEMBEXA enhances the U.S. government’s preparedness to respond to a smallpox emergency, mitigate the risk of the virus developing drug resistance, and provide healthcare professionals with multiple options for therapeutic intervention to save lives in a smallpox emergency, which is in alignment with the Institute of Medicine’s recommendation to develop multiple therapeutics with distinct mechanisms of action against smallpox.

From investing in early innovation, to late-stage development to achieve U.S. Food and Drug Administration (FDA) approval, BARDA focuses on the end goal: ensuring safe and effective products are made available to the American people and the global community to protect health and save lives from health security threats and other public health emergencies. FDA approval, licensure, and clearance for medical countermeasures is a critical milestone for BARDA and its interagency and private sector partners and demonstrates the strength of public-private partnerships in positioning the U.S. to mitigate health security threats through innovation, driving medical countermeasures from bench to bedside, and creating a return on the public investment. Scientists and other technical experts at BARDA are honored to be a part of this endeavor that helps make the world a healthier, safer place. For BARDA, approval number 60 illustrates what government and industry can accomplish together.

Visit BARDA’s FDA approval page to learn more about the public-private partnerships that have achieved the other 59 approvals. While obtaining FDA approval is a major milestone and symbol of development success, regulatory approval is not the end game for public health preparedness and response. Making sure those products are available when needed is the real end game. Each approval offers an opportunity to recognize the collective and collaborative work of the scientific community, government partners and our industry partners to enhance national health security. Approval number 60 highlights just that, 15 years of public and private partnerships to counter health security threats.

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Explore BARDA's CBRN and COVID-19 medical countermeasure portfolio to learn about other exciting products in the pipeline.

Last Updated: June 07, 2021