(RTTNews) - British drug major AstraZeneca Plc (AZN, AZN.L) announced Friday that the US Food and Drug Administration Antimicrobial Drugs Advisory Committee or AMDAC has unanimously recommended Nirsevimab for prevention of respiratory syncytial virus or RSV lower respiratory tract disease in infants.
If approved, nirsevimab would be the first preventive option specifically designed to protect the broad infant population through its first RSV season.
Nirsevimab is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi, using AstraZeneca's YTE technology. Nirsevimab is designed to protect infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
According to the Centers for Disease Control and Prevention or CDC, RSV is a very contagious virus that can lead to serious respiratory illness.
The Committee voted 21 to 0 that AstraZeneca and Sanofi's nirsevimab has a favourable benefit risk profile for the prevention of RSV lower respiratory tract disease or LRTD in newborns and infants born during or entering their first RSV season.
The Committee also voted 19 to 2 in support of nirsevimab's favourable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The company noted that Nirsevimab has the potential to protect the broad infant population through its first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. The single dose can be flexibly administered at the beginning of the RSV season or at birth for newborns born during the RSV season.
The FDA in 2022 accepted the Biologics License Application or BLA for nirsevimab and the agency has indicated it will work to expedite its review. The Prescription Drug User Fee Act date is in the third quarter of 2023. If approved by that time, nirsevimab will be available in the US ahead of the 2023-2024 RSV season.
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