The launch of the drug is significant for India, which is grappling with the growing burden of AMR, or cases where disease-causing pathogens are becoming resistant to existing therapies and treatment options are becoming limited.
The prevalence of UTIs in the Indian population is estimated to be around 33 percent, according to various studies. All UTIs in men—who have less than 15 percent chance of developing this infection in their lifetime as compared to 60 percent in case of women—are considered cUTIs.
In addition, UTIs in immunocompromised patients, pregnant women, and those associated with fevers, stones, diabetes, sepsis, urinary obstruction, catheters, or involving the kidneys are also considered complicated infections. These can, in many cases, lead to urosepsis, which can be fatal in up to 40 percent cases.
“The launch of plazomicin in India will provide access to a novel targeted treatment for cUTI, caused by multidrug resistant organisms and provide physicians with a new once-daily treatment option,” said Dr Jaideep Gogtay, global chief medical officer, Cipla.
While bacteria such as E. coli and possibly Klebsiella overwhelmingly cause simple UTIs, complicated UTIs tend to be caused by a much wider range of organisms which include drug-resistant E. Coli and Klebsiella, Pseudomonas aeruginosa, Enterococcus, and Proteus mirabilis.
In a rising number of cUTIs, doctors are forced to use carbapenems, considered the last line of defence, said Dr Deepti Sureka, consultant female urologist with Asian Institute of Nephrology and Urology in Hyderabad. Carbapenems are a broad spectrum group of antibiotics used to treat infections caused by multidrug-resistant bacteria.
“However, Carbapenem-Resistant Enterobacteriaceae (CRE) are also on the rise, making even the strongest antibiotics ineffective. This not only complicates treatment but also leads to longer hospital stays, higher costs, and increased morbidity,” she told ThePrint.
Cipla says that plazomicin has shown promising activity against CRE.
The drug, approved in 2018 by the US Food and Drug Administration (FDA), was developed by a US-based biotechnology company called Achaogen which later went bankrupt and sold the drug’s patent to Cipla USA as part of the bankruptcy process.
The company said its approval in India 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 (plazomicin) for the treatment of cUTI, including pyelonephritis.
The pharma firm also said it generated Indian-specific pathogen data to address the urgent need for managing CRE.
(Edited by Gitanjali Das)
