Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers.
In addition to these trials, sponsors should take any necessary additional steps ahead of pediatric studies, depending on nonclinical pharmacology and toxicology findings observed in adults. Sponsors should also justify the inclusion of specific populations in drug evaluations, the agency said. Data monitoring committees will likely be necessary for trials involving vulnerable populations such as young children or infants.
Since efficacy endpoints have not yet been established for RSV treatment or prophylaxis clinical trials, sponsors should collaborate with the Division of Antiviral Products to identify reliable endpoints. In Phase 2 trials in particular, the agency strongly recommends exploring several secondary endpoints, such as clinical and virological, to establish consistency with the primary endpoint and serve as a guide for endpoints in later trials.