Tetraphase’s IV Eravacycline Marketing Authorization Application submitted and validated in Europe

Tetraphase Pharmaceuticals, a clinical-stage biopharmaceutical company said on Thursday that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA).

Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit.

“The MAA filing represents a significant milestone for Tetraphase as it is our first regulatory application for marketing authorization and a major step toward making eravacycline available as a new antibiotic treatment option for patients with serious hospital infections,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “I am proud of the dedicated team at Tetraphase who made this  happen and who support our commitment to develop novel antibiotics to treat drug-resistant infections. We look forward to working with the EMA during their review of this application and to focusing on the submission of the New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2018.”