CHMP recommends Xerava to treat complicated intra-abdominal infections.-Tetraphase Pharma.

Tetraphase Pharmaceuticals, Inc., announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending Xerava (eravacycline) for approval as a treatment for adult patients with complicated intra-abdominal infections (cIAI). The CHMP’s opinion will be reviewed by the European Commission (EC) which is expected to make a final decision within three months. If approved by the EC, marketing authorization for Xerava will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.

The CHMP opinion is based on a comprehensive data package from IGNITE1 and IGNITE4, which were part of the Company’s phase III Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) program. In IGNITE1, twice-daily intravenous (IV) Xerava met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV ertapenem in 536 patients using a 10% non-inferiority margin. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV Xerava met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV meropenem in 500 patients using a 12.5% non-inferiority margin. In both IGNITE1 and IGNITE4, Xerava was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The Company is also using the results from IGNITE1 and IGNITE4 to support a NDA for Xerava in cIAI with the FDA.

Comment: "Complicated intra-abdominal infections are increasingly caused by resistant pathogens and appropriate antibiotic therapy is critical to successful outcomes," commented Joseph Solomkin, M.D., Professor Emeritus in the Department of Surgery at the University of Cincinnati College of Medicine and advisor to the Company. "Collectively, the data from the IGNITE program in cIAI versus two widely-used comparators, ertapenem and meropenem, provides compelling evidence for IV eravacycline monotherapy and its potential to be a valuable new addition to the limited toolkit currently available to treat serious, and often life-threatening MDR infections."