CDSCO Panel Rejects Pfizer's Proposal to Waive Phase IV CT of Antimicrobial FDC
New Delhi: Highlighting that there is no unmet need for a Phase IV clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected pharma major Pfizer's proposal for a Phase IV clinical trial study waiver for the antimicrobial fixed dose combination drug (FDC) Avibactam Sodium plus Ceftazidime Powder for concentrated solution for infusion.
This came after the firm presented its proposal before the committee along with the justification for the Phase IV clinical trial study waiver for the antimicrobial fixed dose combination drug (FDC) Avibactam Sodium plus Ceftazidime Powder for concentrated solution for infusion.
Avibactam is a non-β-lactam β-lactamase inhibitor that has been approved in combination with ceftazidime for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and nosocomial pneumonia, including ventilator-associated pneumonia.
It inactivates some 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 the activity of ceftazidime against ceftazidime-resistant, β-lactamase-producing strains.
Ceftazidime is a broad-spectrum, third-generation cephalosporin beta-lactam antibiotic used to treat or prevent a variety of bacterial infections, including pneumonia, gynaecological infections, bone and joint infections, and septicemia, among others.
In Europe, ceftazidime-avibactam is also approved for the treatment of gram-negative infections with limited treatment options.
Earlier, the Medical Dialogue Team had reported that Pfizer had got the go-ahead from the Central Drug Standard Control Organization (CDSCO) panel to import and market the fixed dose combination(FDC) drug containing Avibactam Sodium plus Ceftazidime Powder as a concentrated solution for infusion for an additional indication. Furthermore, the nod was granted with the condition of conducting the Phase IV clinical trial.
Now, in continuation, the expert panel at the recent SEC meeting reviewed the proposal presented by pharma major Pfizer along with the justification for the Phase IV clinical trial study waiver.
Responding to the above, the committee opined that:
1. The product was already approved on February 12, 2021, for a different indication.
2. The request for a Phase III clinical trial study waiver was already considered by the SEC for the proposed product in the proposed indication, for which permission was already issued on October 14, 2022, with the condition to conduct a Phase IV clinical trial study.
3. There is no unmet need for a Phase IV clinical trial study waiver.
After detailed deliberation, reiterating the earlier recommendation, the committee suggested, "The firm should present the Phase IV clinical trial study protocolbefore the committee."
