AstraZeneca Pharma India is preparing to launch Palivizumab (Synagis) in India in October 2024, aiming to prevent severe respiratory syncytial virus (RSV) infections in high-risk infants and children. This introduction follows the receipt of import and market permission from the Drug Controller General of India (DCGI) in September 2023.
Indication and Target Population
Palivizumab (Synagis) is specifically indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by RSV. The target population includes:
- Infants born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
- Children less than 2 years of age requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months.
- Children less than 2 years of age with hemodynamically significant congenital heart disease (CHD).
Dosage and Administration
Synagis will be available as a solution for injection at a concentration of 100 mg/ml (r-DNA origin). It will be offered in 50mg/0.5mL and 100 mg/mL presentations within single-dose vials. The drug is administered intramuscularly, providing a targeted approach to protect vulnerable infants and children from severe RSV-related complications.
