Wockhardt receives QIDP status for antibiotic WCK 6777 from USFDA

Wockhardt has received the Qualified Infectious Disease Product (QIDP) designation for WCK 6777 from the United States Food and Drug Administration (USFDA).

WCK 6777 is a once-a-day combination antibiotic based on Wockhardt's NCE Zidebactam, which imparts WCK 6777 novel mechanism of lactam enhancer.

Being a once-a-day drug, WCK 6777 would be the first ever antibiotic facilitating the treatment of MDR infections in out-patient settings. Wockhardt's other Zidebactam-based product, WCK 5222, has received US FDA's nod for global Phase 3 clinical trial.

WCK 6777 for injection has been awarded QIDP for the following indications: Treatment of complicated urinary tract infections, including pyelonephritis (cUTI) and treatment of complicated intra-abdominal infections (cIAI).

 

The QIDP status is granted to drugs that are effective against a set of multidrug resistant pathogens identified by the CDC (Centre for Disease Control, USA), which have a high degree of unmet need in the treatment of patients infected by such pathogens. The status provides fast track clinical development and review of the drug application by US FDA for approval. The QIDP drug is also entitled for five-year extension of market exclusivity.

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