Aetion Adds Rabies Drug to FDA Decision Alerts Library Following Pediatric RWE Study

The Food and Drug Administration’s Center for Biologics Evaluation and Research has issued approval for a supplemental Biologics License Application (sBLA) for rabies immune globulin drug KEDRAB, manufactured by Kamada. A real world evidence (RWE) study showed efficacy in pediatric patients. Kamada also included data from the Centers for Disease Control and Prevention (CDC) and the Israeli Ministry of Health in its application.

“FDA concluded that the RWE studies, specifically the U.S. data, were sufficient to support the applicant’s pediatric effectiveness claims. The Agency noted that the CDC RWE was reliable because rabies is a reportable disease in the U.S., which ensures all cases are captured.” Read more here.

(Source: Nick Honig and Michelle Skornicki, Aetion, 8/12/21)