Pfizer gets CDSCO Panel nod to study antimicrobial FDC Avibactam plus Aztreonam
Pfizer
New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 2A clinical study of the antimicrobial drug combination Avibactam 0.5 g plus Aztreonam 1.5 g Powder for Concentrate for Solution for Infusion.
This came after the firm presented phase 2A clinical study protocol no. C3601010 dated 27 September 2023.
Avibactam is a non-β-lactam β-lactamase inhibitor used in combination with ceftazidime for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital or ventilator-acquired pneumonia.
Avibactam is a non-β lactam β-lactamase inhibitor that inactivates some β-lactamases (Ambler class A β-lactamases, including Klebsiella pneumoniae carbapenemases, Ambler class C and some Ambler class D β-lactamases) by a unique covalent and reversible mechanism, and protects ceftazidime from degradation by certain β-lactamases. Avibactam rapidly reaches the periplasm of bacteria at high enough concentrations to restore activity of ceftazidime against ceftazidime-resistant, β-lactamase-producing strains. Avibactam does not decrease the activity of ceftazidime against ceftazidime susceptible organisms.
Aztreonam is a beta-lactam antibiotic used to treat select aztreonam-sensitive gram-negative bacteria.
The bactericidal action of aztreonam results from the inhibition of bacterial cell wall synthesis due to a high affinity of aztreonam for penicillin binding protein 3 (PBP3). By binding to PBP3, aztreonam inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that aztreonam interferes with an autolysin inhibitor.
At the recent SEC meeting for Antimicrobial and Antiviral held on September 19, 2024, the expert panel reviewed the phase 2A clinical study protocol no. C3601010 dated 27 September 2023 presented by the drug major Pfizer.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
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