The US Food and Drug Administration has approved Tetraphase Pharmaceuticals’ novel antibiotic drug Xerava (eravacycline), however the drugmaker is hoping that physicians will prescribe the medication responsibly to avoid contributing to antibacterial resistance. The tetracycline class antibacterial is indicated for the treatment of complicated intra-abdominal infections in adult patients, however it should only be used to treat infections that are proven to be caused by bacteria susceptible to the compound.
“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,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “Each milestone is a significant accomplishment on its own and achieving both underscores the potential for Tetraphase and the medical need for Xerava.”
In clinical trials of Xerava, the drug showed non-inferiority to ertapenem and meropenem, two broad-spectrum antibiotics used to treat serious infections. The drug was also generally well-tolerated among study participants and showed high cure rates for patients diagnosed with complicated intra-abdominal infections.
“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 Dr. Philip S. Barie, 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.”
According to Barie, eravacycline has many advantages over conventional treatment for complicated intra-abdominal infections. One of the biggest benefits is that physicians do not need to adjust the dose of the antibiotic given to patients in kidney failure – a seriously ill patient population that can be difficult to treat. Furthermore, patients who are allergic to penicillin can tolerate eravacycline, making it a valuable treatment option for complicated infections.
“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 Dr. Rick A. Bright, 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.”
While intra-abdominal infection is common, the complicated form of this disease affects both the source organ and the peritoneal space which separates tissue in the abdomen. There are multiple different forms of complicated intra-abdominal infection, including abscess, peritonitis, appendicitis and diverticulitis.
Since these infections can be caused by Gram-negative and Gram-positive strains of bacteria, it’s important to identify the type of pathogen, if possible, before choosing which antibiotic is most appropriate to treat it. However, the emergence of drug-resistant bacteria has made it more difficult to treat these complicated intra-abdominal infections using conventional antibiotics.
The FDA released new guidance in May of this year aimed at helping drugmakers develop treatments for complicated intra-abdominal infections. Tetraphase expects to launch Xerava in the US in the fourth quarter of 2018.
*Editor’s Note: A previous version of this article was published under the title “Tetraphase Pharmaceuticals Urges Physicians to Use Caution When Prescribing New Antibiotic Drug Xerava”