Wockhardt’s Zaynich has got US FDA approval and Indian CDSCO marketing authorisation for treating complicated urinary tract infections.
It is a novel injectable antibiotic combining cefepime and zidebactam.
The drug is the first fully indigenously developed Indian new chemical entity to secure US FDA approval.
It offers a potent option against multidrug-resistant gram-negative bacteria amid a thinning global antibiotic pipeline.
Indian pharmaceutical and biotechnology company Wockhardt has announced the regulatory approval of Zaynich, a breakthrough novel antibiotic aimed at treatment of complicated urinary tract infection (cUTI), including pyelonephritis, in adults.
Late last week, the United States Food and Drug Administration (FDA) approved the antibiotic, while the Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) granted import and marketing authorisation of this indigenously discovered and developed drug.
Urinary tract infections are commonly caused by Escherichia coli (E coli) and Klebsiella pneumoniae. cUTIs have even higher risk of treatment failure, with a growing number of them being caused by multidrug-resistant bacteria. Pyelonephritis is a bacterial infection of one or both kidneys, caused by bacteria like E coli, when an infection has moved from bladder (UTI) to the kidneys.
Zaynich is injectable, comprising of cefepime and zidebactam, and indicated to work against E coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex and Pseudomonas aeruginosa.
According to a press release from Wockhardt, this drug is a “life-saving therapeutic option, particularly in carbapenem-resistant infections where current treatment options such as colistin and polymyxins are limited by significant toxicity and suboptimal efficacy”. Colistin and polymyxins are last resort antibiotics used in hospital ICU settings.
“Zaynich has come into the picture after a gap of about 40-50 years with a completely new mechanism of action of Beta-lactam enhancer, targeting gram-negative pathogens,” said Mahesh Patel, chief scientific mentor, drug discovery, Wockhardt, who was involved in co-inventing the drug along with Sachin Bhagwat, chief scientific officer for drug discovery, Wockhardt.
Cefepime and zidebactam work together by binding to multiple penicillin-binding-proteins, leading to bacterial killing. Speaking to the Delhi-based think tank Centre for Science and Environment (CSE), Patel explained that the activity of the beta-lactam antibiotic, cefepime, is enhanced by many fold due to the synergistic action of non-beta lactam drug, zidebactam, thereby making it possible to overcome all existing resistant mechanisms. Antibiotics working on beta-lactamase inhibitor-based approaches are conventional, do not cover all beta-lactamases and all resistant mechanisms.
The arrival of this antibiotic is also a milestone for India, as it is the first 'new chemical entity' fully developed and commercialised by an Indian pharmaceutical company to receive US-FDA approval. It also addresses a critical gap, being uniquely positioned to work against multi-drug resistant gram-negative bacteria, infections caused by which have limited treatment options.
The antibiotic’s journey to the market involved extensive clinical evaluation. It underwent nine Phase 1 studies and a Phase 2 study conducted across 15 leading tertiary care hospitals in India. Phase 2 study demonstrated over 97 per cent clinical efficacy against serious infections, including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, bloodstream infections, complicated intra-abdominal infections and cUTI.
Its Phase 3 Trial (ENHANCE-1 study) involved 530 patients across 64 sites in the US, Europe, India, China and Latin America, wherein the antibiotic showed 89 per cent clinical cure, outperforming meropenem, which showed a 68.4 per cent success rate.
In 2023, CSE researchers had talked about the dry global antibiotic pipeline. The story published in Down To Earth had highlighted how the big pharmaceutical companies have exited this space of antibiotic development, and small and medium scale companies, including Indian companies, are picking up the slack.
Amid existing concerns of weakening antibiotic pipeline, this Indian-made breakthrough emerges as an essential tool for clinicians worldwide. “Zaynich is a global product, meeting the highest unmet medical needs of both developed and developing countries, thereby addressing the global challenge of antimicrobial resistance,” vouched Patel.