Novartis Gets CDSCO Panel Nod To Study Crizanlizumab
New Delhi: Pharmaceutical major Novartis has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct Phase IV clinical trial for Crizanlizumab, a monoclonal antibody that targets selectin to reduce the frequency of vasooclusive crises in patients with sickle cell disease.
Crizanlizumab is a humanized IgG2 monoclonal antibody used to reduce the frequency of vaso-occlusive crises in patients with sickle cell disease. Crizanlizumab binds to P-selectin on endothelial cells and platelets, preventing their interaction with P-selectin glycoprotein ligand 1 on endothelial cells, platelets, red blood cells, and leukocytes. By preventing this interaction, components of the blood are less likely to come together, causing a vaso-occlusive crisis in patients with sickle cell diseases.
At the recent SEC meeting of Oncology & Haematology held on 05.08.2022, the expert panel extensively evaluated the phase IV clinical trial protocol of Crizanlizumab with justification presented by the drug major Novartis.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial with condition that the firm should provide the post-trial access to the trial subject(s) as per the New Drugs and Clinical Trial Rules, 2019.
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