FDA Approves Eravacycline for Complicated Intra-Abdominal Infections

The US Food and Drug Administration (FDA) has approved eravacycline (XERAVA) for the treatment of complicated intra-abdominal infections (cIAI).

Eravacycline, a therapy noted to have a wide profile of antibacterial activity, has been indicated for the treatment of complicated intra-abdominal infections in patients 18 years and older. Its efficacy and safety were established in non-inferiority studies comparing it to the widely-used therapies ertapenem and meropenem.

Intra-abdominal infection (IAI), a common issue in clinical practice, is classified as ‘complicated’ in instances where the infection extends beyond the source organ into the peritoneal space due to perforation or other gastrointestinal tract-related issues. Relevant cIAI diagnoses include intra-abdominal abscess, stomach perforation, peritonitis, appendicitis, etc. Physicians advocate for early detection, containment, and proper treatment of the IAI.

Particularly in an era of growing antibiotic resistance, polymicrobial infection treatment options are limited and in-demand, Philip S. Barie, MD, MBA, professor of surgery and public health in medicine at Weill Cornell Medicine, and attending surgeon at New York-Presbyterian/Weill Cornell Medical Center, said.

“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," Barie said in a statement. “Current empiric treatments for cIAI have limitations, and there is a need for new and novel treatments.”

Barie added that the favorable safety profile of eravacycline, as well as it not requiring dose adjustments in response to treating patients with renal impairment, only bolsters its standing as a standout therapy for its indictation.

“Additionally, the drug may be given safely to patients who are allergic to penicillin,” Barie said. “This new and novel treatment may be of great benefit to patients with complicated intra-abdominal infections."

Guy Macdonald, president and chief executive officer of Tetraphase, noted the company had also received a positive opinion from the European Committee for Medicinal Products for Human Use in this quarter. He called eravacycline’s approval “an extraordinary achievement.”

“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, Macdonald said. “We look forward to a successful launch and commercialization moving forward."