Eravacycline filed at FDA to treat complicated intra-abdominal infections.- Tetraphase.
Tetraphase Pharmaceuticals, Inc. announced that it has submitted its New Drug Application (NDA) to the FDA for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections (cIAI).
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.
Comment:Eravacycline treats infections caused by Gram-negative bacteria such as Escherichia coli and Klebsiella pneumonia, often the cause of dangerous multi-drug-resistant bacterial infections.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.