Wockhardt Submits Marketing Authorisation Application for Breakthrough Antibiotic
Wockhardt has formally submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its innovative antibiotic, WCK 5222, on January 5, 2026.
This esteemed agency assesses new medicinal products for approval across the 27 member states of the European Union, as well as three nations within the European Economic Area, collectively encompassing 30 distinct markets.
WCK 5222 is a fixed-dose amalgamation of Zidebactam and Cefepime, specifically crafted to combat severe Gram-negative infections instigated by multidrug-resistant pathogens.
The EMA has affirmed that this product qualifies for Accelerated Assessment, a regulatory route designed to expeditiously review therapeutics addressing significant unmet medical needs.
The New Drug Application for WCK 5222 is concurrently undergoing a fast-track review by the United States Food and Drug Administration (FDA).
Leveraging comprehensive clinical and regulatory data, Wockhardt anticipates that this antibiotic will be embraced for treating resistant infections in territories governed by the EMA.
This priority designation underscores the urgent, global demand for proficient treatment alternatives against perilous drug-resistant infections.
Significantly, WCK 5222 marks the first novel chemical entity unearthed and developed in India to seek pan-European marketing approval.
Marketed under the brand designation Zaynich®, this antibiotic has recently concluded a global Phase III clinical trial aimed at bolstering regulatory submissions in international jurisdictions.
In parallel, applications have been lodged with Indian regulatory authorities.
Over 50 patients in India and the United States afflicted by severe, resistant infections have received Zaynich® through compassionate use programs.
The drug has also undergone several Phase I trials in the United States and a multi-indication clinical study in India, focusing on carbapenem-resistant infections.
Wockhardt has devoted over 27 years to cultivating a specialized antibiotic discovery program that targets drug-resistant pathogens.
Its development pipeline contains six antibiotics, each at varying stages of advancement, all having received the Qualified Infectious Disease Product designation from the U.S. FDA.
The company employs approximately 2,900 individuals across multiple countries, with its manufacturing and research facilities located in India, the UK, and Ireland, deriving a substantial portion of its revenue from international markets.
Source link: Themachinemaker.com.
