(Released 19 December 2019) Today, the U.S. Department of Health and Human Services (HHS) issued the first Project BioShield contract to fund the advanced development needed to support the expanded use of an existing antibiotic to treat exposure to inhalational anthrax.
Under the contract, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide technical expertise and up to $169 million over 5 years to Paratek Pharmaceuticals, Inc., of Boston, Massachusetts, to complete the studies and manufacturing activities necessary for the U.S. Food and Drug Administration (FDA) to consider emergency use authorization (EUA) of NUZYRA® (omadacycline) to treat people exposed to anthrax.
“BARDA is committed to ensuring that Americans have access to effective antibiotics in the event of an emergency involving anthrax and during other public health emergencies in which drug-resistant bacterial infections complicate doctors’ ability to treat patients,” said Rick Bright, Ph.D., director BARDA and HHS deputy assistant secretary for preparedness and response. “Saving lives after an anthrax attack on our nation means not only having FDA-approved antibiotics readily available to treat anthrax infections but also having products available to combat drug-resistant infections.”
NUZYRA already is approved in intravenous (IV) and oral (tablet) forms for community-acquired bacterial pneumonia and acute skin infections in adults. These infections can complicate responses to public health emergencies, such as natural disasters and influenza pandemics.
If the FDA authorizes NUZYRA for emergency use for anthrax lung infections, BARDA will work with Paratek Pharmaceuticals to purchase an initial supply of the drug to further enhance HHS’ efforts to prepare for potential bioterrorism threats.
If the additional development work is successful, the antibiotic could become the first antibiotic developed and procured through Project BioShield to treat potentially drug-resistant bioterrorism agents.
The Project BioShield Act of 2004 provides HHS with unique legal authorities and dedicated funding to accelerate the late-stage development and purchase of effective medical products to protect Americans against chemical, biological, radiological, and nuclear threats.
Released by the U.S. Department of Health and Human Services. Click here for source.