Nirsevimab shows positive protective profile in RSV

Positive to-line results from the Phase III 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.

Nirsevimab reached its primary endpoint, achieving a statistically-significant absolute reduction of LRTI caused by RSV in healthy preterm and term infants compared to placebo through a typical RSV season. No clinically-meaningful differences in safety results between the nirsevimab and placebo groups were seen. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results.

Results will be presented at an upcoming scientific congress and are anticipated to form the basis of regulatory submissions.