Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity
Joseph B. Domachowske, Shabir A. Madhi, Eric A. F. Simões, Victoria Atanasova, Fernando Cabañas, Kenji Furuno, María Luz García‐García, Ineta Grantiņa, Kim An Nguyen, Dennis Brooks, Yue Chang, Amanda Leach, Therese Takas, Yuan Yuan, M. Pamela Griffin, Vaishali S. Mankad, Tonya Villafana
Abstract
The efficacy and safety of nirsevimab in the treatment of medically attended respiratory syncytial virus (RSV) infections of the lower respiratory tract in otherwise healthy, late preterm and term infants were assessed in the phase 2B1 and phase 3 MELODY2 trials. An ongoing phase 2–3 trial (ClinicalTrials.gov number, NCT03959488. opens in new tab) is evaluating the safety and pharmacokinetics of nirsevimab in infants at risk for severe RSV infection of the lower respiratory tract who are eligible to receive palivizumab. [...]