Kedrion Biopharma and Kamada Receive FDA Approval for KEDRAB
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved Kedrion Biopharma’s and Kamada’s KEDRAB (rabies immune globulin [human]) for passive, transient postexposure prophylaxis of rabies infection when given immediately after contact with a rabid or possibly rabid animal and administered concurrently with a full course of rabies vaccine. Prior to this approval, there were only two other human rabies immune globulin therapy options to prevent the onset of rabies in someone who may have been exposed to the deadly virus.
“The approval of KEDRAB represents the first product that Kedrion Biopharma has had a role in developing throughout its clinical development and through to commercialization in the U.S.,” said Paolo Marcucci, president and CEO of Kedrion. “We are proud that our unique and advanced immune globulin purification technology was used in the development of KEDRAB, and look forward to a successful launch of the product with Kedrion Biopharma,” added Amir London, Kamada’s CEO.
References
- Kedrion Biopharma and Kamada Receive FDA Approval of KEDRAB for Post-Exposure Prophylaxis Against Rabies Infection. Globe Newswire, Aug. 25, 2017. Accessed at www.nasdaq.com/press-release/kedrion-biopharma-and-kamada-receivefda-approval-of-kedrab-for-postexposure-prophylaxis-against-20170825-00194.