Wockhardt gets India nod for antibiotic to treat drug-resistant infections

Wockhardt Ltd has received approval from India's drug regulator to market Zaynich (Zidebactam/Cefepime), an antibiotic developed by the company to treat complicated urinary tract infections, including kidney infections, as well as cases where the infection has spread to the bloodstream.

The approval from the Central Drugs Standard Control Organisation (CDSCO) adds a new product to Wockhardt's anti-infectives portfolio and comes as hospitals continue to grapple with infections that have become resistant to multiple antibiotics.

Gram-negative bacteria are among the leading causes of serious hospital-acquired infections and can become increasingly difficult to treat once resistance develops. Wockhardt said Zaynich has been developed to address such infections, including those driven by metallo-beta-lactamase (MBL) mechanisms, a form of resistance that limits the effectiveness of many existing antibiotics.

The approval is based on results from the Phase III ENHANCE-1 study, which compared Zaynich with meropenem, a widely used antibiotic for severe infections.

According to Wockhardt, 89% of patients treated with Zaynich achieved both clinical recovery and clearance of the infection, compared with 68.4% of patients treated with meropenem. The assessment was carried out about 10 days after treatment ended.

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The company also reported favourable results among patients whose infection had entered the bloodstream. In this group, 89% of patients receiving Zaynich responded to treatment, compared with 44% in the meropenem arm. The findings highlight the drug's potential in patients with more severe infections, Wockhardt said in a statement.

Before the Phase III trial, the antibiotic was studied in nine Phase I trials and a Phase II study involving patients with serious infections that were difficult to treat with existing medicines. Conducted across 15 tertiary care hospitals in India, the Phase II study showed clinical efficacy of more than 97 per cent across conditions including hospital-acquired pneumonia, bloodstream infections, abdominal infections and complicated urinary tract infections, according to the company.

Wockhardt said existing treatment options for some resistant infections are often limited by side effects and lower effectiveness. The company added that Zaynich is intended to provide another treatment option for such patients.
Under compassionate-use programmes, the therapy has been used in 85 patients with highly drug-resistant infections across India, the United States, Malaysia and France where no suitable treatment alternatives were available, according to the company.

The India approval marks the first regulatory clearance announced by Wockhardt for the antibiotic. The company has also submitted applications seeking approval in the United States and the European Union, where reviews are under way. The therapy has received Priority Review, Fast Track and Qualified Infectious Disease Product designations from the US Food and Drug Administration for multiple infection categories.

The approval adds to Wockhardt's antibiotics pipeline, where the company has six programmes at various stages of development and commercialisation targeting infections caused by both Gram-negative and Gram-positive bacteria.