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Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial


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. ....

United States , France General , United Kingdom , Sanofi Pasteur , William Muller , Ann Roberth Lurie , Drug Administration , Northwestern University Feinberg School Of Medicine , Community Trials , European Medicines Agency , National Medical Products Administration , Japan Agency For Medical Research , Healthcare Products Regulatory Agency , China Center , Respiratory Syncytial Virus , Associate Professor , Northwestern University Feinberg School , Scientific Director , Mene Pangalos , Executive Vice President , Reverse Transcriptase Polymerase Chain Reaction , Promising Innovative Medicine , United Kingdom Medicines , Breakthrough Therapy Designation , Drug Evaluation , National Medical Products ,