AstraZeneca India gets CDSCO approval for Palivizumab, a preventive therapy for RSV

In India, Respiratory Syncytial Virus is the most common cause of hospitalization in children <1 years old

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New Delhi: AstraZeneca Pharma India has announced the marketing approval from Central Drugs Standard Control Organization (CDSCO) to import and market ‘Palivizumab’ injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India.
Respiratory Syncytial Virus (RSV) in children is a ‘major’ public health challenge faced across the globe today and is the second most common cause of death in children under 1 year of age (second only to malaria). WHO estimates that RSV accounts for >60% of acute respiratory infections in children and >80% in infants <1 year old. The disease is responsible for nearly 50% of pneumonia cases and up to 90% of bronchiolitis cases among infants.
In India, RSV is the most common cause of hospitalization in children <1 years old.
This innovative therapy is indicated for prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease:
    • Infants born at 35 weeks of gestation or less and <6 months of age at the onset of the RSV season.
    • Children <2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within last 6 months.
    • Children <2 years of age and with haemodynamically significant congenital heart disease (CHD).
Dr Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said: “We are focused on bringing innovative therapies where we believe we can make the most meaningful difference to patients in India. Currently, there is neither a vaccine nor a targeted treatment for RSV in India. Palivizumab however, is the only preventive therapy now approved in India that can help. This regulatory approval reflects country’s commitment towards enhancing RSV care for infants and saving lives. We are happy to be able to bring this therapy in the country and contribute in safeguarding at-risk children through our unwavering science that has the power to transform patient outcomes. We remain committed not only to providing access to existing management options but also to advancing RSV care and management through prevention, diagnosis, and treatment”.