AstraZeneca gets CDSCO Panel nod to study Palivizumab solution for injection

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-27T18:00:09+05:30 | Updated On 27 Jan 2025 6:00 PM IST

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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.

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.

Also Read: Exemed Pharmaceutical Gets CDSCO Panel Nod To Study Elobixibat Tablets 5mg

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751