TP-271 approved for expedited review process

The U.S. Food and Drug Administration has granted a Qualified Infectious Disease Product (QIDP) and Fast Track designations to Tetraphase Pharmaceuticals Inc.'s TP-271 antibiotic candidate, the company announced Thursday.

The TP-271 is an intravenous formula that is financially supported with funding from the National Institutes of Health and its National Institute of Allergy and Infectious Diseases (NAIAID). The antibiotic is being developed as a broad spectrum compound that would counter pathogens considered to have potential as biological weapons and those that are resistant to current antibiotics.

"These important FDA designations provide significant support for the development of new antibiotic treatments for serious and potentially life-threatening respiratory infections, particularly those that are drug resistant," Tetraphase's CEO andPresident Guy Macdonald said. "Our Investigational New Drug application was recently accepted by the FDA, and we look forward to working with our colleagues at NIAID to advance TP-271 into the clinic."

Among these pathogens are Francisella tularensis, also known as tularemia or rabbit fever; anthrax and Yersinia pestis, also known as the plague.

The QIDP and Fast Track designations provide added incentives included extended exclusivity under the Hatch-Waxman Act and priority review status. The second designation is awarded to compounds that address gaps in treatment options for serious and life-threatening diseases and allows the clinical trials and regulatory review processes to be expedited.

Organizations in this story

FDA Office of Medical Products and Tobacco 10903 New Hampshire Ave NE Silver Spring, MD 20903

National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892

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