FDA Publishes Antiviral Guidance

On October 11, 2017, FDA published guidance to assist companies developing drugs for the treatment and prevention of respiratory syncytial virus (RSV) infection. The guidance addresses the overall development program and clinical trial designs for the development of drugs and biologics to treat RSV infection.

FDA states in the guidance that the document “is intended to serve as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public.” While the guidance focuses mainly on drugs for infants and young children, drugs for other age groups are discussed. The guidance also includes sections on nonclinical drug development for prophylaxis and treatment.

The development of drugs that target the host response of RSV infections, vaccines, and blood-derived products are not addressed in the guidance. The guidance does not discuss statistical analysis or clinical trial design.