Medimmune Gets Approval Recommendation For RSV Drug

The Blood Product Advisory Committee of the US Food and Drug Administration has reccommended that Medimmune's intravenous immunoglobulin product, RSV-IGIV, be approved for the treatment of respiratory syncytial virus infection

The latest decision follows the disclosure of data from the Phase III PREVENT trial last year, which showed the drug reduced significantly the incidence of hospitalization related to RSV disease in premature babies and infants with bronchopulmonary dysplasia, according to the company.

An earlier study (CARDIAC), evaluating the product in a separate population of children with congenital heart disease, also suggested a reduction in RSV hospitalization but did not achieve statistical significance.