HHS sponsors new formulation of world’s first approved smallpox drug

To expand U.S. health security and prepare for the potential use of smallpox virus in bioterrorism attacks against the United States, the U.S. Department of Health and Human Services will purchase additional doses of a smallpox antiviral medication called TPOXX for the Strategic National Stockpile and will work with Siga Technologies of New York City to develop an intravenous (IV) formulation of the drug.

Purchase of TPOXX in pill form and development of an IV formulation will be completed under a contract between Siga Technologies and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. BARDA will use funding from the Project BioShield Special Reserve Fund. The contract can be extended for up to 10 years and $629 million if necessary to complete development of the IV formulation.

“We want to save as many lives as possible after a bioterrorism incident involving smallpox, and an IV treatment is essential given that smallpox can damage the throat, making it difficult or impossible to swallow pills,” explained BARDA Director Rick Bright, Ph.D. “This latest agreement with Siga represents an important step in improving our nation’s health security.”

Under the agreement, Siga will conduct the late-stage development and manufacturing work necessary to apply for U.S. Food and Drug Administration approval and to deliver the IV formulation.

Siga also will manufacture and deliver 23,000 new doses of TPOXX in pill form adding to the 2 million treatment courses BARDA has purchased over the past four years for the Strategic National Stockpile using Project BioShield funding.

The FDA approved the oral formulation of TPOXX on July 13, 2018, making it the first approved drug in the world to treat smallpox. The approval culminated 15 years of research and development efforts made possible through public-private partnerships between the company, the Department of Defense, Centers for Disease Control and Prevention, National Institutes of Health, and BARDA. TPOXX is a novel small-molecule drug that blocks the smallpox virus from replicating in the human body until the person’s own immune system can clear the virus.

The new effort is consistent with the principles of the National Biodefense Strategy and National Security Presidential Memorandum which President Trump signed September 18.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. For more about ASPR and BARDA, visit www.phe.gov/aspr. To learn more about partnering with BARDA on advanced development of medical countermeasures – drugs, vaccines and devices for emergencies – visit www.medicalcountermeasures.gov.

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By |2018-09-30T17:53:21+00:00September 30th, 2018|

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