Novel Rabies Prophylaxis Gains FDA Approval

The FDA approval is based on results from a Phase 2/3 clinical study that included 118 individuals
The FDA approval is based on results from a Phase 2/3 clinical study that included 118 individuals

Kedrion Biopharma and Kamada have announced that KEDRAB, a rabies immune globulin has been approved for passive, transient post-exposure prophylaxis of rabies infection by the Food and Drug Administration (FDA).

KEDRAB is a human plasma-derived immune globulin (HRIG) and should be administered concurrently with a full course of rabies vaccine. The treatment is approved for immediate administration following contact with a rabid or possibly rabid animal.

The FDA approval is based on results from a Phase 2/3 clinical study that included 118 individuals. Fifty-nine participants received KEDRAB and 59 received a comparator HRIG at a dose of 20IU/kg intramuscularly on Day 0, and subsequently received rabies vaccine on Days 0, 3, 7, 14 and 28. 

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Results showed that the primary endpoint of non-inferiority of KEDRAB was reached with a difference of -1.8% between the 2 therapies with variability of -8% and 3% (CI 90%). Additionally KEDRAB was were tolerated with no serious adverse events experienced.

“Rabies is a deadly, but entirely preventable disease, and we are pleased to offer physicians another safe and effective option,” said Paolo Marcucci, President and CEO of Kedrion.

Kamada has been selling the HRIG product using the brand name KamRAB in a number of territories outside the U.S. since 2006. Kedrion and Kamada's clinical development and marketing agreement stipulates that upon receipt of FDA marketing approval, Kamada holds the license for KEDRAB and Kedrion Biopharma has exclusive rights to commercialize in the U.S.

For more information visit Kedrion.com.