The Food and Drug Administration (FDA) has approved Merck’s drug for respiratory syncytial virus (RSV) in infants.
Regulators cleared Enflonsia, the monoclonal antibody, for newborns and infants “born during or entering their first RSV season,” the FDA said on June 9.
RSV is a lower respiratory tract disease that spreads in the fall and winter.
“Enflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,” Dr. Dean Y. Li, president of Merck Research Laboratory, said in a statement.
The FDA has not yet released documents outlining the approval.
Merck said the approval was based on the results of a phase 2b/3 placebo-controlled clinical trial that showed that infants who received Enflonsia had reduced risk of contracting RSV-associated medically attended lower respiratory infections and RSV-associated hospitalizations. A separate phase 3 trial found that the antibody reduced the risk of severe RSV disease when compared to palivizumab, an RSV preventative medication, according to Merck….