$WOCKPHARMA

The US Food and Drug Administration (FDA) has approved Wockhardt’s novel antibiotic Zaynich for the treatment of complicated urinary tract infections (cUTIs) in adults caused by designated susceptible microorganisms. Zaynich, a combination of Zidebactam and Cefepime, is indicated for the treatment of complicated urinary tract infections, including pyelonephritis (kidney infections), in adult patients. The approval also extends to cases associated with Gram-negative bacteremia, a serious bloodstream infection caused by bacteria. A day earlier, Wockhardt Ltd announced that it had also secured 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 India. According to the company, the approvals cover adult patients aged 18 years and above suffering from cUTIs, including pyelonephritis, as well as infections accompanied by Gram-negative bacteremia. The regulatory clearances were supported by results from the pivotal ENHANCE-1 study, a multinational, randomized, double-blind Phase 3 clinical trial. The study assessed the efficacy and safety of Zaynich compared with meropenem in patients with complicated urinary tract infections, including pyelonephritis.