FDA OKs Vabomere, New Antibacterial for Complicated UTI

Megan Brooks

Disclosures

August 30, 2017

The US Food and Drug Administration (FDA) has approved (Vabomere, Medicines Company) for adults aged 18 years and older with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by designated susceptible Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex).

Vabomere combines the carbapenem antibacterial agent meropenem with vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

"Carbapenem antibiotics have been the preferred drugs for treating serious infections, such as cUTI, due to Enterobacteriaceae-producing, extended-spectrum beta-lactamases. With the dissemination of the KPC [Klebsiella pneumoniae carbapenemase] enzyme, new drugs that address this resistance mechanism to carbapenems are a welcome addition to our armamentarium," Cornelius Clancy, MD, chief of infectious diseases at the Veterans Affairs Pittsburgh Health System, said in a company news release.

Vabomere received priority review and is expected to be available in the fourth quarter of this year.

"The FDA is committed to making new safe and effective antibacterial drugs available. This approval provides an additional treatment option for patients with cUTI," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release

The safety and efficacy of Vabomere were evaluated in more than 500 adults with cUTI, including those with pyelonephritis. At the end of intravenous treatment, about 98% of patients treated with Vabomere had cure or improvement in symptoms and a negative urine culture, compared with about 94% of patients treated with piperacillin–tazobactam, according to the FDA.

Approximately 7 days after completing treatment, about 77% of patients treated with Vabomere had resolved symptoms and a negative urine culture, compared with about 73% of patients treated with piperacillin–tazobactam.

The recommended dosage of Vabomere is 4 g (meropenem 2 g and vaborbactam 2 g) administered as a 3-hour intravenous infusion every 8 hours in patients 18 years of age and older with an estimated glomerular filtration rate of 50 mL/min per 1.73 m2 or greater. The duration of treatment is up to 14 days.

"To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, Vabomere should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria," the FDA advises.

The most common adverse reactions seen with Vabomere were headache, infusion site reactions, and diarrhea. Vabomere is associated with serious risks, including allergic reactions and seizures. It is contraindicated in patients with known hypersensitivity to meropenem or vaborbactam, or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to β-lactam antibacterial drugs.

Full prescribing information is available online.

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