AstraZeneca PLC on Thursday said that a US Food & Drug Administration committee unanimously recommended its antibody nirsevimab.
Nirservimab for the prevention of respiratory syncytial virus lower respiratory tract disease in infants.
The Cambridge-based pharmaceutical company said that if approved, nirsevimab would be the first preventive option targeted to protect infants through their first RSV season, which typically starts in autumn.
The FDA antimicrobial drugs advisory committee voted 19-2 in favour of a benefit risk profile for nirsevimab for children up to 24 months who remain vulnerable to severe RSV through their second RSV season.
There has been progress on preventative options against RSV in the past weeks.
On Wednesday, Brentford, London-based GSK PLC announced that its RSV vaccine Arexvy became the first EU-approved vaccine against the virus for adults aged 60 and older. In May, the vaccine had received full approval for that age group in the US.
RSV is a common contagious virus affecting the lungs and breathing passages.
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