QIDP designation for Tetraphase's lead antibiotic candidate

The US Food and Drug Administration has designated biotech company Tetraphase Pharmaceuticals’ (Nasdaq: TTPH) lead antibiotic product candidate, eravacycline, as a Qualified Infectious Disease Product (QIDP).

Apart from eravacycline, four of the emerging antibiotics therapies slated to launch by 2021 are Rib-X’s delafloxacin, Furiex’s JNJ-Q2, Trius/Bayer’s tedizolid and Nabriva/Forest’s BC-3781, and these are being developed in both intravenous and oral formulations.

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. Furthermore, if ultimately approved by the FDA, eravacycline is eligible for an additional five-year extension of Hatch-Waxman exclusivity.