Kedrion Biopharma and Kamada Ltd announced that KEDRAB® [rabies immunoglobulin (Human)] has received US Food and Drug Administration (FDA) approval for post-exposure prophylaxis against rabies infection.
Rabies is a life-threatening condition that impacts approximately 40,000 people in USA each year, representing an annual market opportunity of $100 million-plus. Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, upon receipt of FDA marketing approval, Kamada holds the license for KEDRAB®, and Kedrion Biopharma has exclusive rights to commercialize the product in the US, where KEDRAB® will launch in early 2018.
“KEDRAB represents the first product that Kedrion Biopharma has had a role in developing throughout its clinical development and through to commercialization in the US,” said Paolo Marcucci, Chairman and Chief Executive Officer of Kedrion. “Rabies is a deadly, but entirely preventable disease, and we are pleased to offer physicians another therapeutic option.”
“The approval of KEDRAB by the FDA marks an exciting and important milestone in the evolution of Kedrion Biopharma as we continue to grow our US business. As we are one of the world’s leading suppliers of high-titer rabies plasma, we are well-positioned to maximize the potential of this product, and we look forward to working with Kamada to launch KEDRAB in the United States”, Paolo Marcucci concluded.