CDSCO Panel grants Wockhardt's Protocol Amendment Proposal For Cefepime Zidebactam
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Wockhardt protocol amendment proposal to the study the efficacy and safety of Cefepime-zidebactam vs. Meropenem in the treatment of complicated urinary tract infection or acute pyelonephritis in adults.
This came after the drug major Wockhardt presented protocol amendment 1 version 2.0 dated 14 December 2021, protocol no. W-5222-301.
The above study is a phase 3, randomized, double-blind, multicenter, comparative study to determine the efficacy and safety of Cefepime Zidebactam vs. Meropenem in the treatment of complicated urinary tract infections or acute pyelonephritis in adults.
Cefepime-zidebactam (WCK 5222) is a novel bicyclo-acyl hydrazide-containing combination agent that is under investigation for complicated urinary tract infection or pyelonephritis.
WCK 5222 is a novel β-lactam–β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID). ZID is a novel β-lactam enhancer with a dual action of binding to Gram-negative penicillin-binding protein 2 (PBP2) and β-lactamase inhibition.
Zidebactam belongs to the DBO chemical class with dual modes of action. It has β-lactamase inhibitory activity as well as intrinsic antibacterial activity due to selective, high-affinity binding for Gram-negative bacterial PBP2 protein.
Cefepime injection is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
At the recent SEC meeting for Cardiovascular and Renal held on 20th December 2023, the expert panel reviewed the protocol amendment 1 version 2.0 dated 14 December 2021, protocol no. W-5222-301.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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