US FDA Approves Wockhardt's Zaynich for Treatment of Complicated Urinary Tract Infections in Adults

FDA Approves Wockhardt's Antibiotic Zaynich for Complicated Urinary Tract Infections

The US Food and Drug Administration (FDA) has approved Wockhardt's antibiotic Zaynich for the treatment of complicated urinary tract infections (cUTIs) in adults caused by designated susceptible microorganisms. This approval was announced by the company on Thursday.

Zaynich, a combination of Zidebactam and Cefepime, has been cleared for the treatment of complicated urinary tract infections, including kidney infections known as pyelonephritis, in adult patients. The approval also covers cases accompanied by Gram-negative bacteremia, a serious bloodstream infection caused by bacteria.

In addition to the FDA approval, Wockhardt Ltd has also received approval from India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), for the import and marketing of the indigenously discovered and developed antibiotic in the country. The approval is for the treatment of adult patients (18 years and above) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteremia.

Read also: Wockhardt Secures Second US Approval for New Drug, Eyes Commercial Viability

Wockhardt's approval was backed by data from the pivotal ENHANCE-1 study, a multinational, randomised, double-blind Phase 3 clinical trial that evaluated the efficacy and safety of Zaynich against meropenem in patients suffering from cUTI, including pyelonephritis.

According to Wockhardt, the drug demonstrated efficacy against difficult-to-treat Gram-negative bacterial infections, including extensively drug-resistant (XDR) pathogens. The Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, in recognition of its broad-spectrum potential. This designation supports the drug's potential use against clinically significant XDR Gram-negative pathogens in critically ill patients.

Zaynich combines Cefepime, a fourth-generation cephalosporin antibiotic, with Zidebactam, a novel beta-lactam enhancer developed by Wockhardt.