Posted by Michael Wonder on 27 Feb 2018
Tetraphase Pharmaceuticals announces FDA acceptance for filing of its NDA submission for eravacycline for the treatment of complicated intra-abdominal infections
27 February 2018 - PDUFA date set for 28 August 2018.
Tetraphase Pharmaceuticals today announced that it has received notification from the U.S. FDA 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 (cIAI), and determined that the application is sufficiently complete to permit a substantive review.
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.
