The US Food and Drug Administration has approved a new antibacterial drug to treat patients with complicated urinary tract infections (UTI).
Rempex Pharmaceuticals’ Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.
The therapy can now be prescribed by physicians to treat UTIs including a certain kidney infection, pyelonephritis, caused by specific bacteria.
Its safety and efficacy was assessed in a clinical trial involving 545 adults with cUTI. Around 98 percent of patients treated with Vabomere versus approximately 94 percent of patients treated with piperacillin/tazobactam had cure/improvement in symptoms and a negative urine culture test.
Seven days after completing treatment, 77 percent of patients treated with Vabomere compared with 73 percent of patients treated with piperacillin/tazobactam had resolved symptoms and a negative urine culture, regulator noted.
The most common adverse reactions in patients taking Vabomere were found to be headache, infusion site reactions and diarrhoea.