CDSCO Panel Approves Wockhardt's Protocol Amendment Proposal for antimicrobial drug Cefepime plus Zidebactam

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Wockhardt's protocol amendment proposal for the fixed-dose combination (FDC) antimicrobial drug Cefepime plus Zidebactam.

This came after the firm presented protocol amendment 1, version 2.0, dated 27 June 2024 protocol No. W-5222-202.

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.

Cefepime inhibits bacterial cell wall synthesis by covalently binding enzymes responsible for the final step in transpeptidation during peptidoglycan wall synthesis. This binding causes defects in the cell wall, leading to autolysis and subsequent death of the organism.

Zidebactam is a β-lactam enhancer antibiotic with a dual mechanism of action involving binding to Gram-negative PBP2 and β-lactamase inhibition. Cefepime combined with zidebactam (WCK 5222) is under clinical development for the treatment of Gram-negative infections.

At the recent SEC meeting for Antimicrobial and Antiviral held on 22nd August 2024, the expert panel reviewed the protocol amendment, version 2.0 dated 27 June 2024 protocol No. W-5222-202 presented by Wockhardt

After detailed deliberation, the committee recommended the approval of protocol amendment as presented by the firm.

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