Wockhardt gets CDSCO Panel Nod to study antimicrobial FDC Cefepime plus Tazobactum
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to the drug major Wockhardt to conduct the trial of the antimicrobial fixed-dose combination drug Cefefime plus Tazobactum.
This came after the firm Presented Phase II/III Clinical Trial Protocol No. W-4282-303.
Tazobactam is a beta-lactamase inhibitor administered with antibiotics such as piperacillin and ceftolozane to prevent their degradation, resulting in increased efficacy. Tazobactam is an antibiotic of the beta-lactamase inhibitor class that prevents the breakdown of other antibiotics by beta-lactamase enzyme-producing organisms. It is combined with Piperacillin and Ceftolozane for the treatment of a variety of bacterial infections.
Tazobactam broadens the spectrum of piperacillin and ceftolozane by making them effective against organisms that express beta-lactamase and would normally degrade them. This occurs through the irreversible inhibition of beta-lactamase enzymes. In addition, tazobactam may bind covalently to plasmid-mediated and chromosome-mediated beta-lactamase enzymes. Tazobactam is predominantly effective against the OHIO-1, SHV-1, and TEM groups of beta-lactamases, but may also inhibit other beta-lactamases.
Cefepime is used in the treatment of bacterial infections. Cefepime is an antibiotic. It kills bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive.
Cefepime is a bactericidal cephalosporin with a mode of action similar to other beta-lactam antibiotics. Cefepime disrupts bacterial cell walls by binding and inhibiting transpeptidases known as penicillin-binding proteins (PBPs), which are enzymes involved in the final stages of peptidoglycan layer synthesis.
Cefepime plus Tazobactum is used in the treatment of bacterial infections. Cefepime plus Tazobactum is a combination of two medicines: Cefepime and Tazobactum. Cefepime is an antibiotic. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria in the human body.
At the recent SEC meeting for the antimicrobial and antiviral held on 31 October 2023, the expert panel reviewed phase II/III clinical trial protocol no. W-4282-303 presented by Wockhardt.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as per the proposed protocol presented by the firm.
