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.