The US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to Tetraphase Pharmaceuticals' lead antibiotic product candidate, eravacycline.
The QIDP designation, granted for complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI) indications, will make eravacycline eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, eravacycline is eligible for an additional five-year extension of Hatch-Waxman exclusivity.
Eravacycline is being developed as a broad-spectrum IV and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multi-drug resistant infections, including multi-drug resistant Gram-negative infections. Tetraphase is planning to advance eravacycline into phase III clinical studies in cIAI and cUTI in the second half of this year.
“We are delighted that our lead antibiotic product candidate, eravacycline, has received QIDP designation under the GAIN Act for both cIAI and cUTI indications. We believe it is the first product candidate to receive this designation in cIAI,” said Guy Macdonald, Tetraphase president and chief executive officer. “Antibiotic resistance, particularly among the difficult-to-treat populations with Gram-negative infections, represents a potential global health crisis.”
The GAIN Act, Title VIII (Sections 801 through 806) of the FDA Safety and Innovation Act, seeks to provide pharmaceutical and biotechnology companies with incentives to encourage the development of new drugs to treat, prevent, detect and diagnose antibiotic-resistant infections. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening multi-drug resistant infections.