Pharmaceutical firm Wockhardt has received approval from the USFDA for Zaynich (cefepime and zidebactam), a novel antibiotic for the treatment of adults with complicated urinary tract and kidney infections, adding a new treatment option in the fight against antimicrobial resistance.

The approval comes days after India's drug regulator granted marketing authorisation for the therapy and follows positive results from the global Phase 3 ENHANCE-1 study, which evaluated the drug against meropenem, a widely used antibiotic.

Wockhardt said the approval makes Zaynich the first new chemical entity (NCE), or a completely new drug, fully developed and commercialised by an Indian pharmaceutical company to receive US FDA approval.

"This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance," said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group.

"Furthermore, ZAYNICH is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry," he added.

The approval was based on results from the Phase 3 ENHANCE-1 trial involving 530 patients across 64 hospitals and research centres in the US, Europe, Latin America, China and India. The study compared Zaynich with meropenem in hospitalised adults suffering from complicated urinary tract infections and acute kidney infections.

According to Wockhardt, 89% of patients treated with Zaynich showed both clinical recovery and elimination of the infection, compared with 68.4% of patients receiving meropenem, giving the drug a treatment advantage of 20.6 percentage points.

The antibiotic has been developed to treat some of the most difficult drug-resistant bacterial infections, where existing treatment options are often limited. The company said the therapy works through a dual-action mechanism that helps it overcome several forms of bacterial resistance.

"The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations," said Dennis Deruelle, Chief Medical Officer at Wockhardt.

The approval comes at a time when antimicrobial resistance continues to pose a growing healthcare challenge globally. Wockhardt cited data showing that more than 2.8 million antimicrobial-resistant infections occur annually in the US, resulting in over 35,000 deaths.

Keith Kaye, Professor of Medicine and Division Chief for Infectious Diseases at Rutgers Robert Wood Johnson Medical School, said the approval addresses a pressing medical need.

"Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system, as patients with these infections typically require longer, more intensive care, and are at increased risk of life-threatening complications," he said.

"There is an ongoing need for new antibiotics to combat these drug-resistant pathogens, and we are pleased that this approval means patients will soon have an exciting unique option that is urgently needed in the US and worldwide."

Zaynich had earlier received Priority Review and Fast Track designations from the US FDA, programmes intended to speed up the development and review of medicines that address significant unmet medical needs. It has also received Qualified Infectious Disease Product status, a special FDA designation aimed at encouraging the development of urgently needed antibiotics.

The company said the therapy has also been made available through expanded access programmes in multiple countries for patients with limited treatment options.

The latest approval strengthens Wockhardt's antibiotics business. The company currently has six antibiotic programmes at different stages of development and commercialisation, all of which have received Qualified Infectious Disease Product (QIDP) designation from the US FDA.

Wockhardt has also submitted a marketing authorisation application for the drug in Europe, where it is currently under regulatory review.