Tetraphase announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections (cIAI).
The NDA was supported by data from the Phase 3 trials, IGNITE1 and IGNITE 4. In the studies, IV eravacycline twice daily achieved high clinical cure rates in patients with cIAI, and was well tolerated. Eravacycline proved statistically non-inferior to ertapenem and meropenem in IGNITE1 and IGNITE4, respectively, meeting the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.
Eravacycline, a fully-synthetic fluorocycline antibiotic, has demonstrated potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.
Eravacycline is also being investigated in IGNITE3, another Phase 3 trial evaluating once-daily IV eravacycline in patients with complicated urinary tract infections (cUTI).
For more information call (617) 715-3600 or visit tphase.com.