Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial
Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization in all infants.
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Nirsevimab is being investigated as a first-in-class single dose immunization to provide protection for all infants entering their first RSV season.
Nirsevimab met its Phase 3 primary endpoint earlier than anticipated; regulatory submissions for all-infant indication to begin in 2022.
PARIS
– April 26, 2021 – Positive topline results from the Phase 3 MELODY trial showed nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention (inpatient or outpatient) due to respiratory syncytial virus (RSV) in healthy preterm and term infants. RSV is the most common cause of LRTI and the leading cause of hospitalizations in all infants.