Public Health Emergency - Leading a Nation Prepared
Advanced research and development is underway for an antibiotic that potentially could treat children infected with anthrax, tularemia or community-acquired bacterial pneumonia. The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) will support this advanced research and development under a two-year, $17.7 million contract with Cempra Pharmaceuticals of Chapel Hill, N.C.
“The needs of special populations including children are paramount in public health emergency preparedness,” said BARDA Director Robin Robinson, Ph.D. “The development of this new antibiotic could help address a gap in our nation’s preparedness and could bolster clinicians’ ability to treat drug-resistant bacterial infections, which represent a growing public health threat.”
The contract supports studies needed to request U.S. Food and Drug Administration (FDA) approval of a drug called solithromycin. If approved, the drug would be the first orally administrated antibiotic (taken by mouth) approved in decades to treat children who develop community acquired bacterial pneumonia. This type of pneumonia is developed in the community rather than in a hospital.
Studies of the drug’s use in treating anthrax or tularemia will be conducted under the FDA’s Animal Efficacy Rule and could provide additional treatment options for clinicians’ use in a public health emergency involving these bioterrorism infections. The FDA’s Animal Efficacy Rule allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans.
Solithromycin has demonstrated efficacy in adults with community acquired bacterial pneumonia and uncomplicated urogenital gonorrhea. In late 2012, Cempra initiated a global multi-center clinical trial of orally administered solithromycin in patients with community acquired bacterial pneumonia. The study will be complete in the first half of 2014, and data from the study will be used, in part, to determine the advanced research and development activities supported under the contract.
The project with Cempra is one of several new projects supporting antibiotic candidates added to the existing BARDA antimicrobial drug portfolio this year. BARDA is seeking additional proposals for broad-spectrum antimicrobials that could potentially treat or prevent illness due to biological threat agents. Proposals are accepted through a Broad Agency Announcement BARDA-BAA-12-100-SOL-00011 at www.fbo.gov.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.
The Office of the Assistant Secretary for Preparedness and Response (ASPR) is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.
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