Submit Interim Safety, Efficacy Data: CDSCO Panel Tells Novartis on Crizanlizumab
New Delhi: Reviewing the status of the ongoing studies of Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novartis to submit interim safety and efficacy data of ongoing Phase IV study in India along with periodic safety update report (PSUR) data in Indian population immediately to the authority.
This came after the drug major Novartis presented the status of the ongoing studies with the product Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), in light of regulatory action by European Medicines Agency (EMA) on marketing authorization (MA) of the product Crinzalizumab(Adakveo),
Crizanlizumab is 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. Sickle cell disease is a genetically inherited condition prevalent in the Middle East, Africa, and certain parts of India. The genetic mutation associated with this disease leads to the formation of abnormal, sickle-shaped red blood cells that aggregate and block blood vessels throughout the body, causing vaso-occlusive crises. Sickle cell disease can lead to excruciating pain, stroke, infection, and various other complications arising from the blockage of blood vessels.
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 for the Haematology held on 5th March 2024, the expert panel reviewed the status of the ongoing studies with the product Crizanlizumab concentrate for a solution for infusion 10mg/mL (100mg/10mL).
After detailed deliberation, the committee recommended the firm submit interim safety and efficacy data of the ongoing Phase IV study in India along with PSUR data in the Indian population immediately to CDSCO for further evaluation by the committee.
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