Tetraphase Announces FDA Approval of XERAVA (Eravacycline) for cIAI

Tetraphase Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval of XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem.

XERAVA is indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

“The approval of XERAVA is an extraordinary achievement, one for which we thank the patients who have participated in our clinical studies, study investigators and physicians as well as our dedicated employees,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “We are thrilled to have received FDA approval, and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe all within the same quarter. Each milestone is a significant accomplishment on its own and achieving both underscores the potential for Tetraphase and the medical need for XERAVA.”

Mr. Macdonald added, “We will now turn our efforts towards delivering XERAVA to patients suffering from cIAI in the United States, an important goal we expect to begin executing on in the fourth quarter of this year. We look forward to a successful launch and commercialization moving forward.”

“Complicated intra-abdominal infections are the second-most prevalent infection site in intensive care units (ICUs), as well as the second leading cause of infection-related mortality in ICUs,” said Philip S. Barie, MD, MBA, Professor of Surgery and Professor of Public Health in Medicine at Weill Cornell Medicine, and an attending surgeon at New York-Presbyterian/Weill Cornell Medical Center in New York City. “With the growing crisis of antibiotic resistance, treatment options for these polymicrobial infections are limited following surgery or percutaneous drainage, and the causative pathogens may be multi-drug resistant. Current empiric treatments for cIAI have limitations, and there is a need for new and novel treatments. Eravacycline has a broad spectrum of antibacterial activity and a clinical profile that addresses this unmet medical need.”

Dr. Barie added, “Eravacycline also has a favorable safety profile as observed in clinical trials, and no dose adjustment is required when given to patients with renal impairment, which is advantageous for seriously ill patients who may have impaired kidney function. Additionally, the drug may be given safely to patients who are allergic to penicillin. This new and novel treatment may be of great benefit to patients with complicated intra-abdominal infections.”

Intra-abdominal infection (IAI) is a common problem in clinical practice and comprises a wide variety of disease processes. IAI is classified as uncomplicated or complicated based on the extent of the infection. Complicated intra-abdominal infections (cIAI) extend beyond the source organ into the peritoneal space (the space between the two membranes that separate the organs in the abdominal cavity from the abdominal wall) as a result of perforation or other damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. Different bacterial pathogens are responsible for cIAI, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. Early detection, containment and appropriate antimicrobial treatment are essential to the successful treatment of IAI. This is even more critical with increasing rates of infections caused by drug-resistant bacteria, which limit the effectiveness of currently available antibiotics.

“Today’s FDA approval of XERAVA provides a new weapon in the battle against antibiotic resistance and addresses an unmet medical need for patients suffering from multi-drug resistant infections and other serious infections” said Rick A. Bright Ph.D., Director of the Biomedical Advanced Research and Development Authority (BARDA). “We are pleased to have provided support to Tetraphase since 2012, through its collaboration with CUBRC, to develop this new antibiotic treatment. The drug’s approval underscores the value of public-private partnerships in addressing global health threats and the challenge of antibiotic resistance.”