FDA Approves Eravacycline for Adults With Complicated Intra-Abdominal Infections

Officials with the FDA have approved eravacycline (XERAVA, Tetraphase Pharmaceuticals), a fluorocycline antibacterial within the tetracycline class of antibacterial drugs, for the treatment of complicated intra-abdominal infections (cIAI) in patients aged 18 years and older.^1,2 According to the FDA, eravacycline is indicated for patients with cIAI caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis.¹

To reduce the development of drug-resistant bacteria and maintain the effectiveness of eravacycline and other antibacterial drugs, the newly approved product should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, the FDA said, in a statement. Eravacycline is not indicated for the treatment of complicated urinary tract infections.¹

“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, in a prepared statement.² “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.”

The recommended dosage of eravacycline approved by the FDA is 1 mg/kg by intravenous infusion over approximately 60 minutes every 12 hours for a total duration of 4 to 14 days. The duration of therapy should be guided by the severity and location of infection and the patient’s clinical response.¹

Efficacy of XERAVA was demonstrated in two Phase 3, randomized, double-blind, active-controlled, multinational, multicenter trials in adult patients hospitalized with cIAI.¹ According to Tetraphase, the drug 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.²

The most common adverse reactions (incidence ≥ 3%) to eravacycline are infusion site reactions, nausea, and vomiting. The use of eravacycline may also cause tooth discoloration and enamel hypoplasia, inhibition of bone growth, and clostridium difficile-associated diarrhea.¹

Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA, and use of the product should be discontinued if an allergic reaction occurs.¹ The product is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients.¹

“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,” said Barie, in a prepared statement.² “This new and novel treatment may be of great benefit to patients with complicated intra-abdominal infections.”

References

• FDA Approves XERAVA (Eravacycline) for Complicated Intra-Abdominal Infections in Patients 18 Years of Age and Older [news release]. Silver Spring, MD; August 28, 2018; FDA website. http://www.pharmacytimes.com/link/213. Accessed Aug. 29, 2018.
• Tetraphase Pharmaceuticals announces FDA approval of Xerava™ (eravacycline) for complicated intra-abdominal infections (cIAI) [news release]. Watertown, MA; August 27, 2018: Tetraphase Pharmaceuticals website. https://ir.tphase.com/node/10121/pdf. Accessed August 29, 2018.