Cipla proposal to market Plazomicin with clinical trial waiver rejected by CDSCO panel
New Delhi: Rejecting pharma major Cipla's proposal to import and market Plazomicin 50mg/ml injection with a local clinical trial waiver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has opined the firm to conduct a Phase III clinical trial in the country and accordingly submit the Phase III clinical trial protocol to CDSCO for further review.
This came in the wake of the proposal presented by the firm to import and marketing of Plazomicin 50mg/ml injection with local clinical trial waiver before the committee.
Plazomicin is a parenterally administered, broad spectrum aminoglycoside antibiotic typically used for moderate-to-severe urinary tract infections or pyelonephritis.
Plazomicin mediates the antibacterial activity against pathogens including carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae. It mediates the antibacterial activity by binding to bacterial 30S ribosomal subunit and inhibiting protein synthesis Label.
Earlier the Medical Dialogues Team had reported that the U.S. Food and Drug Administration (FDA) had approved ZEMDRI (plazomicin) for adults with complicated UTI, including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options, announced the biopharmaceutical company Achaogen, Inc.
Also Read: Plazomicin New Drug For Approval For Complicated UTI
At a recent SEC meeting held on 26th November, 2021 the committee thoroughly examined the drug-maker Cipla's proposal for the import and marketing of the Plazomicin 50mg/ml injection.
After extensive evaluation, the committee observed that, justification for local clinical trial waiver was not adequate as per rules and there is no unmet medical need for the proposed indication in the country.
After detailed deliberation, the committee did not recommend for local clinical trial waiver and opined that, the firm should conduct Phase III clinical trial in the country.
Accordingly, the committee directed the firm to submit the Phase III clinical trial protocol to CDSCO for further review by the committee.
