CDSCO Approves safety, efficacy data with DMC report for Novartis' antimalarial drug Cipargamin
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the safety and efficacy data with the DMC (Data Monitoring Committees) report presented by the drug major Novartis for malaria drug Cipargamin (KAE609) study.
This came after the drug maker Novartis presented safety and efficacy data with a DMC report compliant with condition No. 4 of CT(clinical trial) NOC for protocol No. CKAE609B12201.
The purpose of this study is to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
The study also intends to evaluate clinical treatment success using a novel clinical endpoint for drug development in severe malaria.
Severe malaria is a medical emergency and is affecting primarily young children in Africa. Injectable artesunate is the standard of care for the treatment of severe malaria and is highly efficacious. However, the spread of artemisinin-resistance in Plasmodium falciparum in Asian countries poses a threat for future treatment of patients with this life-threatening disease. To mitigate this risk, there is a need of another drug in malaria endemic countries. Cipargamin treatment results in rapid clearance of parasites including artemisinin resistant parasites.
Cipargamin (KAE609) is an experimental synthetic antimalarial drug belonging to the spiroindolone class.
Cipargamin acts on the PfATP4, which is a P-type Na + ATPase disrupting the Na + homeostasis in the parasite. Cipargamin is a very fast-acting antimalarial, it is active against all intra-erythrocytic stages of the malaria parasite and exerts gametocytocidal activity, with transmission-blocking potential.
At the recent SEC meeting for Antimicrobial and Antiviral, the expert panel reviewed the safety and efficacy data with DMC report in compliance to condition No. 4 of CT NOC for protocol No. CKAE609B12201 presented by the drug major Novartis.
After detailed deliberation, the committee accepted the safety and efficacy data with the DMC report in compliance with condition No. 4 of the CT NOC as presented by the firm.
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