FDA Awards Fast Track Status To Tetraphase's Eravacycline
Tetraphase Pharmaceuticals announced that it has received Fast Track designation for both intravenous (IV) and oral formulation of its lead antibiotic candidate eravacycline from the U.S. Food and Drug Administration (FDA).
Eravacycline is a new, fully synthetic tetracycline antibiotic under development as a broad spectrum intravenous and oral antibiotic for the treatment of multidrug-resistant (MDR) infections, including those caused by MDR Gram-negative bacteria.
Fast Track status is awarded to speed the study and regulatory review of drugs intended for the treatment of serious or life-threatening conditions as well as those that address unmet medical needs. Eravacycline was designated as a Qualified Infectious Disease Product (QIDP) which made it eligible for Fast Track designation. The QIDP designation also makes the drug qualified for priority review and an additional five years of market exclusivity in the U.S. once approved. The incentives are part of the Generating Antibiotic Incentives Now Act (GAIN Act), enacted in July 2012 as part of the FDA Safety and Innovation Act (FDASIA).
Guy Macdonald, President and CEO of Tetraphase, said, “We are delighted that eravacycline has received Fast Track designation for both formulations and for both therapeutic indications being pursued. 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.”
The drug is currently undergoing investigation in Phase III global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline). IGNITE 1 is evaluating eravacycline in complicated intra-abdominal infections (cIAI) and IGNITE 2 in complicated urinary tract infections (cUTI).