CDSCO Panel Approves Pfizer's Protocol Amendment Proposal to Study Aztreonam and Avibactam

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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