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.^1-5
• 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.^1-5

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.

“Despite respiratory syncytial virus being the leading cause of pneumonia and bronchiolitis in the first year of life, there is no routine preventative option currently approved for all infants,” said Dr William Muller, Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial. “These exciting trial data demonstrate the potential for nirsevimab to change the prevention landscape not only by providing protection to a broad population of infants across the full respiratory syncytial virus season, but also by achieving this with a single dose.”