Wockhardt secures US FDA approval for antibiotic Zaynich

Indian drug major Wockhardt’s breakthrough antibiotic Zaynich (cefepime and zidebactam), a drug that works on superbugs or bacterial infections that show resistance against existing antibiotic treatments, has received novel drug approval from the US Food and Drug Administration (FDA).

The approval is “to treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms,” according to the latest information on the USFDA website.

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Earlier on Thursday, Wockhardt announced that the Indian regulator Central Drugs Standard Control Organisation (CDSCO) had granted authorisation for the import and marketing of Zaynich in India.

“The Indian approval is for treatment of adult patients with complicated urinary tract infections (UTI), including pyelonephritis, as well as cases with concurrent Gramnegative bacteremia,” the company said in its statement on Thursday.

Zaynich is being seen as a game-changing drug in treating drug-resistant gram-negative pathogens (pathogens that are difficult to kill) and has a market opportunity of about $9 billion.

India loses 10 lakh people due to multi-drug resistance every year (4 times of Covid), while worldwide the number is 5 million (twice as much as Covid).

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The customer group for Zaynich is the same for other antimicrobial drugs from Wockhardt such as Emrok, Wck 6777, and others that are used to treat drug resistant bacterial infection in hospitals and ICUs. End

Talking to ET last year, on the possible pricing of the drug, Wockhardt chairperson Habil Khorakiwala had said that the treatment cost for most new products launched in the last 10 years in the US have been in the range of $10,000-$15,000 per treatment (of 8-10 days) and Zaynich price will also hover in that range. India price will be significantly lower, he had said.