Kedrab Labeling Updated With Pediatric Safety, Efficacy Data

The Food and Drug Administration (FDA) has approved updated labeling for Kedrab® (rabies immunoglobulin) [human]) to establish safety and efficacy in children.

Kedrab is a human rabies immunoglobulin indicated for passive, transient prophylaxis after exposure of rabies infection to individuals of all ages, when given immediately after contact with a rabid or potentially rabid animal. It must be co-administered 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) evaluating the efficacy and safety of Kedrab for post-exposure prophylaxis in 30 patients, ages 0.5 to 14 .9 years evaluated . The results showed that Kedrab was well tolerated and effective. Of the 30 patients, 28 (93.3%) achieved rabies virus neutralizing activity, titer 0.5 IU/ml or greater (WHO recommended level) by day 14. None of the patients followed to the end of the study (n=28) developed rabies infection through Day 84.

Based on claims data, 172 U.S. children were treated with Kedrab between 2018 and 2020. According to the Centers for Disease Control and Prevention, between 2018 and April 2021, not a single child in the U.S. was treated with prophylaxis after rabies exposure.

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Kedrab is available as single-use vials containing 2 ml or 10 ml ready-to-use solution with a potency of 150 IU/ml.

Reference

Kedrion and Kamada announce FDA approval of the update to the Kedrab® label, confirming its safety and effectiveness in children. [press release]. Fort Lee, NJ and Rehovot, Israel: Kedrion Biopharma and Kamada Ltd.; June 2, 2021.

Subjects:

Infectious Disease Rabies Viral Infections

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