The Food and Drug Administration (FDA) has approved updated labeling for Kedrab® (rabies immune globulin [human]) establishing its safety and efficacy in children.
Kedrab is a human rabies immunoglobulin indicated for passive, transient postexposure prophylaxis of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. It should be administered concurrently with a full course of rabies vaccine.
The updated labeling is based on data from an open-label, single-arm, phase 4 study (ClinicalTrials.gov Identifier: NCT02912845) that evaluated the efficacy and safety of Kedrab for postexposure prophylaxis in 30 patients ranging in age from 0.5 to 14.9 years. Results demonstrated that Kedrab was well tolerated and effective. Of the 30 patients, 28 (93.3%) achieved a day 14 rabies virus neutralizing activity titer 0.5 IU/mL or greater (WHO recommended level). None of the patients who were followed until the end of the study (n=28) developed rabies infection through day 84.
Between 2018 and 2020, 172 US children were treated with Kedrab, based on claims data. According to Centers for Disease Control and Prevention, no children in the US treated with postexposure prophylaxis have been reported to have had rabies between 2018 and April 2021.
Kedrab is available as single-use vials containing 2mL or 10mL of ready-to-use solution with a potency of 150 IU/mL.
Kedrion and Kamada announce FDA approval of Kedrab® label update, confirming safety and effectiveness in children. [press release]. Fort Lee, NJ and Rehovot, Israel: Kedrion Biopharma and Kamada Ltd.; June 2, 2021.