AstraZeneca gets CDSCO Panel nod to study Palivizumab solution for injection

New Delhi: Citing that clinical trial sites should be geographically distributed, including government sites, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major AstraZeneca to conduct the study of Palivizumab solution for injection 50 mg/0.5 mL and 100 mg/mL.

This came after AstraZeneca presented the proposal to conduct a Phase IV clinical trial titled “A Multicentre, Interventional, Phase IV, Open-label Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease” via Protocol No. D4800L00014 Version 1.0 dated 09 Sep 2024.

Palivizumab is a monoclonal anti-respiratory syncytial virus F protein antibody used to prevent serious sequelae caused by respiratory syncytial virus infection in pediatric patients. It works by helping the immune system to slow or stop the spread of the virus in the body. Palivizumab, a recombinant humanized monoclonal antibody that provides passive immunity against RSV, acts by binding the RSV envelope fusion protein (RSV F) on the surface of the virus and blocking a critical step in the membrane fusion process.