Tetraphase announces FDA acceptance of NDA submission for Eravacycline
Tetraphase Pharmaceuticals announced that it has received notification from the U.S. Food and Drug Administration that the FDA has completed its initial 60-day review of the New Drug Application for eravacycline for the treatment of complicated intra-abdominal infections, and determined that the application is sufficiently complete to permit a substantive review. The PDUFA 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 3 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 visit.