AstraZeneca India gets CDSCO Marketing Approval for Palivizumab, a Preventive Therapy for RSV

According to reports,  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 one year of age (second only to malaria).

AstraZeneca Pharma India, a leading biopharmaceutical company has received marketing approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute '˜Palivizumab' injection 100 mg/ml (r-DNA origin) in India.

The injection is available in 50mg/0.5mL & 100 mg/mL presentations and is administered through single-dose vials via the intramuscular route.

According to reports, 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 one year of age (second only to malaria).

This significant move aimed at the prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV. Palivizumab injection is said to provide passive immunisation against RSV which means the antibodies slow down or stop the spread of the virus in the body thereby protecting babies from serious infection.

Reportedly, children who are at high risk of RSV disease include- infants born at 35 weeks of gestation or less and who are less than six months of age at the onset of the RSV season. Likewise, children who are less than two years of age and have required treatment for bronchopulmonary dysplasia (BPD) within the last six months and children who are less than two years of age and have haemodynamically significant congenital heart disease (CHD).

He said this regulatory approval reflects the country's commitment towards enhancing RSV care for infants and saving lives.

According to WHO estimates, RSV is responsible for more than 60% of acute respiratory infections in children and over 80% in infants who are less than one year old.

Moreover, the disease accounts for nearly half of pneumonia cases and up to 90% of bronchiolitis cases among infants. Currently, RSV is the most common cause of hospitalisation in children who are less than one year old in India.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas - oncology, cardiovascular, renal & metabolism and respiratory.

Established in 1979, in India, the company aims to deliver life-changing medicines to patients through innovative science and global excellence in development.

Recently, AstraZeneca's rare disease unit Alexion bought Pfizer Portfolio. It signed a licence and purchase agreement for a rare disease programme portfolio from Pfizer Inc. The acquisition of a preclinical rare disease gene therapy programme portfolio from Pfizer is reported to be approximately $1 billion.