Conduct phase 3 trial of Nafamostat Mesilatefor for marketing approval: CDSCO panel tells Cipla
New Delhi: Rejecting drug maker Cipla's proposal to market and manufacture Nafamostat Mesilate for injection at 50 mg/vial and 100mg/vial, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has asked the firm to conduct the phase III clinical trial and, accordingly, submit the phase III clinical trial protocol to CDSCO for further review by the committee.
This came after the drug maker presented their proposal for approval to manufacture and market Nafamostat Mesilate for injection 50 mg/vial and 100mg/vial with a clinical trial waiver.
Nafamostat Mesylate is the mesylate salt form of nafamostat, a broad-spectrum, synthetic serine protease inhibitor, with anticoagulant, anti-inflammatory, mucus clearing, and potential antiviral activities.
The drug nafamostat is used in Asian countries as an anticoagulant therapy for patients undergoing continuous renal replacement therapy due to acute kidney injury. Adding to this, the drug is used as an anticoagulant in patients with disseminative blood vessel coagulation, hemorrhagic lesions, and hemorrhagic tendencies.
At the 88th SEC meeting for Cardiology & Renal held on 15.07.2021, 16.07.2021 & 19.07.2021 at CDSCO, the committee extensively evaluated the proposal presented by the drug-maker Cipla for manufacturing and marketing of Nafamostat Mesilate for injection 50 mg/vial & 100mg/vial with Clinical trial waiver.
Following extensive deliberation, the committee noted that the firm presented very old data and the drug did not fall under any criteria for clinical trial waiver as per rules.
Accordingly, after detailed deliberation, the committee didn't recommend approval of the drug with a clinical trial waiver.
However, the committee opined that the firm should conduct the phase III clinical trial and, accordingly, the firm should submit the phase III clinical trial protocol to CDSCO for further review by the committee.
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