Pfizer gets CDSCO Panel nod to import, and market Aztreonam plus Avibactam Powder
New Delhi: The drug major Pfizer has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market the antimicrobial fixed-dose combination (FDC) of Aztreonam 1.5 gm plus Avibactam 0.5gm powder for concentrate for solution for infusion with the condition to conduct the Phase IV clinical trial.
This came after drugmaker Pfizer presented the proposal before the committee. The firm informed that the said FDC is already approved in Belgium, Bulgaria, Czechia, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Croatia, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden, and the United Kingdom (Northern Ireland).
Furthermore, the firm presented a Phase III clinical trial (CT) report including the Indian subpopulation (27 subjects at 7 sites) as a global clinical trial.
Aztreonam is the first member of a new class of beta-lactam antibiotics, the monobactams. Aztreonam 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, that 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 the active enzyme for hydrolysis and thus decreases the inactivation of the β-lactam antibiotic.
At the recent SEC meeting for antimicrobials and antivirals, the expert panel reviewed the proposal presented by the drug major Pfizer.
After detailed deliberation, the committee recommended the grant of permission to import and market the FDC with the condition of conducting the Phase IV clinical trial.
Accordingly, the expert panel suggested the firm submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC for review by the committee.
