Type of medical product:

Protein based

Novelty:

Biosimilar

Field:

Infectious diseases

Indications for use:

Prevention of severe lower respiratory tract infection in children below 2 years of age

Status:

Preclinical trials in vivo

The agent is a humanized monoclonal antibody IgG1K interacting with epitope A of fusion protein (protein F) antigen of respiratory syncytial virus (RSV). It has prominent neutralizing and inhibitory activity against А and В subtypes of fusion proteins of RSV strains.

It is applied as a preventive treatment against respiratory syncytial virus (RSV)-induced severe lower respiratory tract infection in children with high risk of RSV infection, which are as follows: children below 6 months of age, born before 35 weeks of gestation; children below 2 years of age in need of treatment for bronchopulmonary dysplasia within last 6 months; children below 2 years of age with hemodynamically relevant congenital heart defects. 

Respiratory syncytial virus is a major cause of lower respiratory tract infections in newborns and children. There is no vaccine against the virus. 

Respiratory syncytial virus is related to ubiquitous infections. RSV-induced infection is the most frequent hospital admission reasons for nursing infants in developed countries. Such hospital admission rate ranges from 90,000 to 150,000 in the USA annually. Incidence peaks at the first 2 years of life. About 50% of children acquire respiratory syncytial virus at their 1st year of life and about 25% — at the 2nd. Repeated infection might develop at any age and sometimes it is seen the same winter. Annual repeated infection risk in school-children is 20%. 
In nursing infants RSV-induced infection is a cause of 11 to 15% of out-patient visits. About 10% of these children require in-patient care and more than 80% of severe infections are seen at the age of 1 to 6 months. Severe infection risk is elevated in children with cardiac and respiratory disorders, especially with bronchopulmonary dysplasia and congenital heart defects. 

Preterm neonates and children with suppressed immune protection also develop severe lower respiratory tract disorders. Prominent cell immunity impairment might result in infection persistence and progression. At early postnatal period viral infection is rare, however, nosocomial infection outbreaks in neonatal care units have been described.