AstraZeneca gets CDSCO Panel nod to study Palivizumab solution for injection

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.

Palivizumab injection is used to prevent serious lung infection in children and babies caused by respiratory syncytial virus (RSV). It belongs to a group of medicines known as immunizing agents. This medicine works by giving your body antibodies to protect it against RSV infection.

At the recent SEC meeting for pulmonary, the expert panel reviewed the proposal presented by AstraZeneca Pharma India 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”.

After detailed deliberation, the committee recommended conducting the study as per the protocol presented by the firm, with the condition that clinical trial sites should be geographically distributed, including government sites.

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