FDA accepts NDA for eravacycline for the treatment of complicated intra-abdominal infections - Tetraphase Pharmaceuticals.

Tetraphase Pharmaceuticals, Inc.has announced that it has received notification from the FDA that the FDA has completed its initial 60-day review of the New Drug Application (NDA) for eravacycline for the treatment of complicated intra-abdominal infections (cIAI), and determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA�s review of the eravacycline NDA is set for August 28, 2018. This date reflects a priority 6-month review period.

The NDA submission includes data from the IGNITE1 and IGNITE 4 phase III clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI. Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators � ertapenem in IGNITE1 and meropenem in IGNITE4 � for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.