CDSCO approval granted for Palivizumab preventive therapy

The company highlighted the current absence of both a vaccine and RSV, however, with the CDSCO approval of Palivizumab preventive therapy, there's a ray of hope

The Health Master

October 1, 2023

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Last Updated on October 9, 2024 by The Health Master

CDSCO approval

CDSCO approval: AstraZeneca Pharma India Ltd., a leading science-driven biopharmaceutical company, has achieved a significant milestone with the Central Drugs Standard Control Organisation (CDSCO) granting approval for the import and marketing of ‘Palivizumab’ in India.

This breakthrough therapy is poised to combat Respiratory Syncytial Virus (RSV), a formidable global public health challenge, especially affecting young children.

RSV is currently the second-leading cause of infant mortality worldwide, trailing only behind malaria.

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Understanding the RSV Challenge

Global Impact of RSV:
- The World Health Organization (WHO) estimates that RSV accounts for more than 60% of acute respiratory infections in children, with the figure surging to over 80% in infants under one year old.
- Shockingly, this disease is responsible for nearly half of all pneumonia cases and can lead to up to 90% of bronchiolitis cases among infants.
RSV in India:
- In India, RSV is the primary cause of hospitalization among children under one year old, underscoring the urgency for effective preventive measures.

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The Lifesaving Palivizumab

Targeted Protection:
- Palivizumab is an innovative therapy engineered to shield high-risk children from severe lower respiratory tract diseases necessitating hospitalization due to RSV infections.
Identifying High-Risk Groups:
- This therapy is specifically tailored for:
  - Infants born at 35 weeks of gestation or less who are under six months old at the start of the RSV season
  - Children below two years of age who have undergone treatment for bronchopulmonary dysplasia (BPD) in the past six months
  - Children below two years old with significant congenital heart disease (CHD)

A Milestone in Infant Healthcare

Dr. Sanjeev Panchal, Country President and Managing Director of AstraZeneca India, expressed his dedication to introducing groundbreaking therapies that promise a profound positive impact on patients in India.

This milestone reflects India’s commitment to elevating RSV care for infants and ultimately saving lives.

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