Novo Nordisk Gets CDSCO Panel Nod to Study Ziltivekimab
New Delhi: The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical study of the monoclonal antibody Ziltivekimab.
This came after the drug major Novo Nordisk presented Phase III clinical study protocol No. NN6018-4914.
Ziltivekimab is under development for the treatment of chronic kidney disease and anemia, atherosclerotic cardiovascular disease, heart failure with mildly reduced or preserved ejection fraction (systolic and diastolic heart failure), chronic kidney disease, and systemic inflammation.
Ziltivekimab, a fully human monoclonal antibody directed against Interleukin-6 (IL-6), is being developed to reduce the risk of major adverse cardiovascular events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation.
Ziltivekimab markedly reduced biomarkers of inflammation and thrombosis relevant to atherosclerosis. Based on these data, a large-scale cardiovascular outcomes trial will investigate the effect of ziltivekimab in patients with chronic kidney disease, increased high-sensitivity CRP, and established cardiovascular disease. Novo Nordisk.
At the recent SEC meeting Cardiovascular held on 9th January 2023, the expert panel reviewed the Phase III clinical study protocol No. NN6018-4914.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
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