FDA Fast Tracks IV and Oral Formulations of Eravacycline
Tetraphase Pharmaceuticals today announced that the FDA has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antibiotic candidate, eravacycline. Tetraphase is investigating the safety and efficacy of eravacycline in its ongoing Phase 3 global clinical program; the IGNITE 1 study is evaluating the IV formulation of eravacycline for the treatment of complicated intra-abdominal infections (cIAI); IGNITE 2 is evaluating eravacycline IV-to-oral step-down therapy for the treatment of complicated urinary tract infections (cUTI).
Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Eravacycline became eligible for Fast Track status as a result of being designated a Qualified Infectious Disease Product (QIDP); the QIDP designation also makes eravacycline eligible for priority review and an additional five years of U.S. market exclusivity, if approved. These incentives are part of the Generating Antibiotic Incentives Now Act (GAIN Act), which was enacted in July 2012 as part of the FDA Safety and Innovation Act (FDASIA) and was part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).
“We are delighted that eravacycline has received Fast Track designation for both formulations and for both therapeutic indications being pursued,” said Guy Macdonald, President and CEO of Tetraphase. “There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections, particularly those caused by multidrug-resistant Gram-negative bacteria. With eravacycline and our pipeline of novel antibiotic candidates, we are attempting to directly address this threat. We look forward to working closely with the FDA as we continue to advance eravacycline through Phase 3 development and through the preparation and submission of our NDA filing, which is targeted for the end of 2015.”