FDA Panel Recommends Approval of RSV Preventive Therapy for Infants

An FDA advisory committee has recommended an injectable monoclonal antibody drug called nirsevimab, which functions similarly to a vaccine, to protect infants up to 2 years old from respiratory syncytial virus (RSV). The drug, sold under the name Beyfortus, was found to lower the risk of developing respiratory disease from RSV that required a doctor's visit by nearly 75% for at least five months. The FDA must now decide whether to approve the injection, but is likely to follow the committee’s recommendation. No RSV vaccine for infants has been approved yet.