FDA approves Wockhardt antibiotic Zaynich for complicated urinary tract infections
Big news in medicine: the FDA just approved Zaynich, a fresh antibiotic from Wockhardt, to treat tough urinary tract infections (cUTI).
Zaynich uses a unique combo, cefepime and zidebactam, with a beta-lactam enhancer trick that blocks bacteria in two ways.
This means it can take on almost all known drug-resistant bugs.
Zaynich offers $9B US market opportunity
Zaynich has an estimated market opportunity of about $9 billion and targets a real need: more than 600,000 cUTI hospitalizations happen every year in the US
With more than 2.8 million antimicrobial-resistant infections causing more than 35,000 deaths annually, this approval feels like a big deal.
Wockhardt expects US market exclusivity until around 2038. The drug's development started back in 2011 but hit delays during clinical trials because of the Russia-Ukraine war.
Mahesh Patel from Wockhardt called the approval "It is a big achievement for Wockhardt," against superbugs.