The US Food and Drug Administration has approved cefepime and zidebactam (ZAYNICH) for the treatment of adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative pathogens, according to a press release from Wockhardt.
Keith Kaye, MD, MPH, Professor of Medicine and Division Chief for Infectious Diseases at Rutgers Robert Wood Johnson Medical School, said, “Multidrug-resistant bacterial infections are a substantial burden for patients and the health care system, as patients with these infections typically require longer, more intensive care, and are at increased risk of life-threatening complications.”
The approval was based in part on findings from the phase 3 ENHANCE-1 trial, a randomized, double-blind, multicenter study that enrolled 530 patients with complicated urinary tract infections (cUTI) or acute pyelonephritis across 64 sites in the US, Europe, Latin America, China, and India. Researchers reported that cefepime and zidebactam achieved a composite clinical cure and microbiologic response rate of 89% at the test-of-cure visit compared with 68% for meropenem. The treatment was generally well tolerated.
According to Wockhardt, cefepime and zidebactam combines a fourth-generation cephalosporin with a non-beta-lactam antibacterial and beta-lactamase inhibitor. The company stated that the agents act synergistically by binding multiple penicillin-binding proteins, including PBP1a/b, PBP2, and PBP3.
cUTIs account for more than 600,000 hospitalizations annually in the US, according to the press release. Wockhardt also cited federal estimates indicating that more than 2.8 million antimicrobial-resistant infections occur annually in the US and result in more than 35,000 deaths.
The US Food and Drug Administration granted cefepime and zidebactam Priority Review, Fast Track, and Qualified Infectious Disease Product designations. The approved indication includes infections caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa. Wockhardt reported that it has also submitted a Marketing Authorization Application to the European Medicines Agency.
Source: Wockhardt