CDSCO Panel Approves Pfizer's Protocol Amendment Proposal to Study Aztreonam and Avibactam
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Pfizer to study Aztreonam and Avibactam compared to the best available therapy for serious gram-negative infections.
This came after the firm presented protocol amendment 3 dated 10 June 2024 protocol No. C3601008. The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
Aztreonam is the first member of a new class of beta-lactam antibiotics, the monobactams. Azitreonam is selectively active against Gram-negative aerobic bacteria and inactive against Gram-positive 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.
Avibactam is a novel non-β-lactam β-lactamase inhibitor that inhibits a wide range of β-lactamases. These include class A, class C, and some class D enzymes, which erode the activity of β-lactam drugs in multidrug-resistant pathogens like Pseudomonas aeruginosa and Enterobacteriaceae spp.
The mechanism of β-lactamase inhibition used by avibactam is similar to that of previous β-lactamase inhibitors. Through covalent binding of the β-lactamase active site hydroxyl group, avibactam diminishes the availability of active enzyme for hydrolysis and thus decreases inactivation of the β-lactam antibiotic.
At the recent SEC meeting for antimicrobials and antivirals held on 22nd August 2024, the expert panel reviewed protocol amendment 3 dated 10 June 2024 protocol No. C3601008 presented by the drug major Pfizer.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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