FDA Approves Vabomere for Complicated UTIs
IV antibiotic sanctioned for certain complicated urinary tract infections, including pyelonephritis
WEDNESDAY, Aug. 30, 2017 (HealthDay News) -- The intravenous antibiotic Vabomere (meropenem and vaborbactam) has been approved by the U.S. Food and Drug Administration to treat certain complicated urinary tract infections, including pyelonephritis.
The drug was evaluated in clinical testing involving 545 adults with complicated urinary tract infections. Some 98 percent of patients treated with Vabomere had a negative urine culture test, compared with 94 percent of those treated with another antibacterial drug, the FDA said in a news release. The most common adverse reactions to Vabomere included headache, allergic-like reactions at the injection site, and diarrhea. Users also may be prone to severe allergic reactions, the agency said.
To lessen the chances of fostering drug-resistant germs, Vabomere should only be used to treat or prevent infections by susceptible bacteria, the FDA warned.
"The FDA is committed to making new safe and effective antibacterial drugs available," Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This approval provides an additional treatment option for patients with complicated urinary tract infection, a type of serious bacterial infection."
Approval for Vabomere was granted to Rempex Pharmaceuticals, based in San Diego.