An FDA advisory committee on Thursday will consider whether to recommend a shot of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease in both infants and in at-risk children up to age 2 years.
The Antimicrobial Drugs Advisory Committee will examine a biologics license application approval for nirsevimab, a long-acting RSV fusion protein inhibitor monoclonal antibody that’s delivered via intramuscular injection. Nirsevimab’s developer is AstraZeneca.
Its proposed indication will be prevention of lower respiratory tract disease due to RSV in neonates and infants born during or entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
Panelists will vote on two questions about the risk-benefit profile of the drug for both populations, and will consider two additional discussion questions. One is to consider the risk-benefit by chronological or gestational age group and determine whether there is a population or subpopulation for whom the prophylactic is most appropriate.
The other discussion question asks panelists to assess what additional data may be helpful to inform future recommendations about the drug’s use in infants born to mothers who were vaccinated against RSV. Indeed, another FDA advisory committee recently voted to recommend approval of Pfizer’s RSV vaccine in the second or third trimester of pregnancy to prevent respiratory tract illness in infants.