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.
Sickle cell disease (SCD) is a group of inherited red blood cell disorders. Red blood cells contain hemoglobin, a protein that carries oxygen. Healthy red blood cells are round, and they move through small blood vessels to carry oxygen to all parts of the body. In someone who has SCD, the hemoglobin is abnormal, which causes the red blood cells to become hard and sticky and look like a C-shaped farm tool called a "sickle." The sickle cells die early, which causes a constant shortage of red blood cells. Also, when they travel through small blood vessels, they get stuck and clog the blood flow. This can cause pain and other serious complications (health problems) such as infection, acute chest syndrome, and stroke.
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.
