Drugmaker has received the regulatory green signal from the Food and Drug Administration (USFDA) for its Zaynich (cefepime and zidebactam), a novel intravenous antibiotic to treat adults with complicated urinary tract infections (cUTI) – marking a milestone in its research.
Dr Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group said, 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.” The drug addresses one of the most urgent global health threats —antimicrobial resistance, he said.
Dennis Deruelle, Wockhardt Chief Medical Officer, further explained, “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens,” said Dennis Deruelle, Wockhardt Chief Medical Officer, explaining the significance of the approval. The company’s stock price soared on the BSE, up over 11 percent at Rs 2269, on Monday (10.57 am).
Last week, Zaynich was approved by the Drugs Controller General of India (DCGI). Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency, it said.
Zaynich (cefepime and zidebactam) is an injectable antibiotic comprising cefepime, a cephalosporin antibacterial drug and zidebactam, a non-β-lactam antibacterial and β-lactamase inhibitor, the company said.
In the US, Zaynich had received the Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
It has also been made available through expanded access programs in multiple countries including the US for patients with limited treatment options, the company said.
Unlike most other beta-lactam combinations, Zaynich targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously, a note from the company said.
“This unique, multi-target synergy provides bactericidal activity against the most challenging drug-resistant Gram-negative bacteria for which there are currently very limited treatment options,” it added.
cUTI is responsible for over 600,000 hospitalizations in the US annually, Wockhardt said. And a growing number of cUTIs are caused by antimicrobial resistant bacteria, including multidrug-resistant bacteria, a leading cause of bacteremia and associated with significant morbidity and mortality and a burden on the health care system.
Details of the clinical trial
The FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of Zaynich, compared with meropenem in the treatment of hospitalized adults with cUTI or acute pyelonephritis (AP), it said.
Zaynich demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89 percent versus 68.4 percent for meropenem, the company said, adding that Zaynich was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the US, Europe, LATAM, China and India, and spanned across 64 sites.
The product is contraindicated in patients with a known history of serious hypersensitivity to the components of Zaynich (cefepime and zidebactam) or other beta-lactam antibacterial drugs, the company said, giving adverse events.