Cipla becomes first to launch AMR drug ‘ZEMDRI’ in India
New Delhi: Cipla Limited has launched 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 the susceptible microorganism(s) such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. This launch reiterates Cipla’s commitment to tackling emerging healthcare crises, like anti-microbial resistance (AMR).
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 underlying problem in the urinary tract, such as structural or functional abnormality, like kidney stones or diabetes. The emergence of drug resistant uropathogens has posed a big challenge in management of UTIs. The approval of ZEMDRI was supported by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which was the first randomized 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 Limited, said, “The launch of Plazomicin in India marks an important milestone in introducing treatments for healthcare crises of the future. We are proud to be the first pharmaceutical company to launch ZEMDRI® in India and remain committed to developing a robust antimicrobial portfolio, forging partnerships with thought leaders and industry alliances to ensure global access to antimicrobial drugs for a healthier life.”
Dr. Jaideep Gogtay, Global Chief Medical Officer, Cipla Limited, said, “Cipla has always recognised the need for addressing the growing challenge of AMR. With introduction of ZEMDRI®, Cipla fortifies its commitment to pioneering antimicrobial innovation and ensuring better outcomes for patients with drug-resistant infections. 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 Inc., 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.
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