The US Food and Drug Administration (FDA) has approved eravacycline (Xerava, Tetraphase Pharmaceuticals) for treatment of complicated intra-abdominal infections (cIAIs) in adults age 18 years and older, the company has announced.
Eravacycline is an injectable, fully synthetic fluorocycline antibiotic belonging to the tetracycline group of antibiotics.
In clinical trials, eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI and was statistically noninferior to two widely used comparators (ertapenem and meropenem), the company said in a news release.
"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," Philip Barie, MD, attending surgeon at New York-Presbyterian/Weill Cornell Medical Center in New York City, said in the release.
"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," he added.
Barie noted that eravacycline has shown a favorable safety profile in clinical trials, and there is no need to adjust the dose in patients with renal impairment. The drug may also be given safely to patients with penicillin allergy. "This new and novel treatment may be of great benefit to patients with complicated intra-abdominal infections," he said.
Since 2012, the Biomedical Advanced Research and Development Authority (BARDA) has provided support to Tetraphase, through its collaboration with the private nonprofit company CUBRC, to develop eravacycline. "The drug's approval underscores the value of public-private partnerships in addressing global health threats and the challenge of antibiotic resistance," said BARDA director Rick Bright, PhD.
The company expects eravacycline to be available later this year.
Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of eravacycline cIAIs in adults, as reported by Medscape Medical News.
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Cite this: FDA Approves New Antibacterial Eravacycline (Xerava) - Medscape - Aug 28, 2018.