AstraZeneca India gets CDSCO approval for ‘Palivizumab’ preventive therapy against respiratory syncytial virus

New Delhi [India]: AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company, has received marketing approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market ‘Palivizumab,’ a vital preventive therapy for Respiratory Syncytial Virus (RSV), in India, according to an official release.

RSV poses a significant global public health challenge, particularly affecting children, and stands as the second most common cause of death in infants under one year of age, following only malaria.

The World Health Organization (WHO) estimates that RSV accounts for over 60 per cent of acute respiratory infections in children and more than 80 per cent in infants under one year old.

This disease is responsible for nearly 50 per cent of pneumonia cases and up to 90 per cent of bronchiolitis cases among infants. In India, RSV is the leading cause of hospitalization in children under one year old.

‘Palivizumab,’ an innovative therapy, is designed to prevent severe lower respiratory tract diseases that require hospitalization due to RSV infection in children at high risk.

These high-risk groups include infants born at 35 weeks of gestation or less and under six months old at the onset of the RSV season, children under two years of age who have received treatment for bronchopulmonary dysplasia (BPD) within the last six months, and children under two years of age with significant congenital heart disease (CHD).

Dr Sanjeev Panchal, Country President and Managing Director of AstraZeneca India, stated, “We are dedicated to introducing innovative therapies that can have a significant positive impact on patients in India. Currently, India lacks both a vaccine and a targeted treatment for RSV.

However, Palivizumab, the preventive therapy now approved in India, can make a difference. This regulatory approval reflects the country’s commitment to enhancing RSV care for infants and saving lives.

We are pleased to bring this therapy to the country, contributing to the protection of at-risk children through our unwavering scientific capabilities, which have the potential to transform patient outcomes.

Our commitment extends not only to providing access to existing management options but also to advancing RSV care through prevention, diagnosis, and treatment.”

AstraZeneca is a global biopharmaceutical company focusing on the discovery, development, and commercialization of prescription medicines. Operating in over 100 countries, AstraZeneca’s medicines are used by millions of patients worldwide.

Established in 1979, AstraZeneca Pharma India Ltd. is headquartered in Bengaluru, Karnataka, and employs about 1,000 professionals dedicated to delivering innovative medical solutions to patients.