FDA News

FDA approves Vabomere for complicated urinary tract infections

Ed Cox
Edward Cox

The FDA recently announced the approval of Vabomere as a treatment option for adults with complicated urinary tract infections, or cUTIs, including pyelonephritis.

Vabomere (Rempex Pharmaceuticals) is an antibacterial drug containing meropenem and vaborbactam, an agent that inhibits certain antibiotic resistance mechanisms, according to an FDA news release.

“The FDA is committed to making new safe and effective antibacterial drugs available,” Edward Cox, MD, director of the FDA’s Office of Antimicrobial Products, said in the release. “This approval provides an additional treatment option for patients with cUTI, a type of serious bacterial infection.”

The approval is based on results of a clinical trial in which 545 adults with cUTIs received either meropenem/vaborbactam or Zosyn (piperacillin/tazobactam, Pfizer). At the end of IV treatment, approximately 98% of patients who received meropenem/vaborbactam had resolved or improvements in symptoms and a negative urine culture test vs. 94% of patients who received piperacillin/tazobactam, according to the FDA. In addition, an estimated 77% of patients in the meropenem/vaborbactam arm vs. 73% of patients in the piperacillin/tazobactam arm had resolved symptoms and a negative urine culture approximately 7 days after completing treatment.

The most common adverse events associated with meropenem/vaborbactam included headache, reactions at the infusion site and diarrhea. The drug is also associated with serious risks such as allergic reactions and seizures. The FDA said it should not be used in patients with a history of anaphylaxis. To reduce the development of drug-resistant bacteria, the agency recommended that meropenem/vaborbactam be used only to treat or prevent cUTIs that are confirmed or strongly suspected to be caused by susceptible bacteria.

Disclosure: Cox reports no relevant financial disclosures.

Ed Cox
Edward Cox

The FDA recently announced the approval of Vabomere as a treatment option for adults with complicated urinary tract infections, or cUTIs, including pyelonephritis.

Vabomere (Rempex Pharmaceuticals) is an antibacterial drug containing meropenem and vaborbactam, an agent that inhibits certain antibiotic resistance mechanisms, according to an FDA news release.

“The FDA is committed to making new safe and effective antibacterial drugs available,” Edward Cox, MD, director of the FDA’s Office of Antimicrobial Products, said in the release. “This approval provides an additional treatment option for patients with cUTI, a type of serious bacterial infection.”

The approval is based on results of a clinical trial in which 545 adults with cUTIs received either meropenem/vaborbactam or Zosyn (piperacillin/tazobactam, Pfizer). At the end of IV treatment, approximately 98% of patients who received meropenem/vaborbactam had resolved or improvements in symptoms and a negative urine culture test vs. 94% of patients who received piperacillin/tazobactam, according to the FDA. In addition, an estimated 77% of patients in the meropenem/vaborbactam arm vs. 73% of patients in the piperacillin/tazobactam arm had resolved symptoms and a negative urine culture approximately 7 days after completing treatment.

The most common adverse events associated with meropenem/vaborbactam included headache, reactions at the infusion site and diarrhea. The drug is also associated with serious risks such as allergic reactions and seizures. The FDA said it should not be used in patients with a history of anaphylaxis. To reduce the development of drug-resistant bacteria, the agency recommended that meropenem/vaborbactam be used only to treat or prevent cUTIs that are confirmed or strongly suspected to be caused by susceptible bacteria.

Disclosure: Cox reports no relevant financial disclosures.