Cipla launches ZEMDRI (Plazomicin) in India, aims to tackle AMR
Plazomicin is a novel anti-microbial with demonstrated activity against multi-drug resistant (MDR) bacteria and clinical efficacy in complicated Urinary Tract infections (cUTI)
Cipla announced the launch of ZEMDRI (Plazomicin), a novel treatment for complicated Urinary Tract Infections (cUTI), including pyelonephritis in India. Plazomicin is a new intravenous (IV) aminoglycoside indicated in patients 18 years of age or older for the treatment of cUTIs, including pyelonephritis caused by susceptible microorganisms (s) such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. Through this launch, Cipla aims to tackle the emerging anti-microbial resistance problem.
UTIs are a global health problem affecting approximately 150 million patients each year. UTIs are called cUTIs (complicated UTIs) when they occur in those with an underlying problem in the urinary tract, such as a structural or functional abnormality, like kidney stones or diabetes. The emergence of drug-resistant uropathogens has posed a big challenge in the management of UTIs. The approval of ZEMDRI was supported by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which
was the first randomised controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including pyelonephritis. Additionally, Plazomicin has shown promising activity against Carbapenem-resistant Enterobacteriaceae (CRE), a key challenge in managing resistant infections in India. Cipla has generated Indian-specific pathogen data to address this urgent need, and Plazomicin has shown promising activity against Indian multi-drug resistant (MDR) isolates, including those expressing PBP-3 inserts.
Umang Vohra, Managing Director and Global CEO, Cipla, said, “The launch of Plazomicin in India marks an important milestone in introducing treatments for healthcare crises of the future.”
Dr Jaideep Gogtay, Global Chief Medical Officer, Cipla, said, ” This launch will provide access to a novel targeted treatment for cUTI, caused by multi-drug resistant organisms and provide physicians with a new once-daily treatment option.”
Cipla USA, a subsidiary of Cipla, holds the patent for Plazomicin sulphate (ZEMDRI). ZEMDRI has received Fast Track Status (2012), Qualified Infection Disease Product (QIDP, 2015) and Breakthrough Therapy Designation (2017) from USFDA.