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Kedrion and Kamada Announce FDA Approval of KEDRAB® Label Update, Confirming Safety and Effectiveness in Children
- Label Expansion Differentiates KEDRAB® as the First and Only Human Rabies Immune Globulin (HRIG) Available in the U.S. to be Clinically Studied in Children
About this update from Kamada Ltd.
[{"type":"text","content":"- Label Expansion Differentiates KEDRAB® as the First and Only Human Rabies Immune Globulin (HRIG) Available in the U.S. to be Clinically Studied in Children\n - KEDRAB Product Label Now Includes Patients of All Ages\n - New FDA Approval Based on Safety and Effectiveness of KEDRAB in the Pediatric Population Demonstrated in a U.S. Post Marketing Clinical Trial\n - World Health Organization Estimates up to 40 Percent of People Exposed to a Suspected Rabid Animal are Children Under 15 Years of Age\n\n\nFORT LEE, N.J. and REHOVOT, Israel, June 2, 2021 /PRNewswire/ -- Kedrion Biopharma and Kamada Ltd. (NASDAQ: KMDA) and (TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has approved a label update for KEDRAB® (Rabies Immune Globulin [Human]), establishing the product's safety and effectiveness in children. \n\n \n \n \n \n \n \n\n \nLabel Expansion Differentiates KEDRAB® as First and Only Human Rabies Immune Globulin in U.S. to be Studied in ChildrenKEDRAB, a human rabies immune globulin (HRIG), is now indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ages when given promptly following contact with a rabid or possibly rabid animal. The new updates to the KEDRAB label are based on data from the KEDRAB U.S. post marketing Pediatric Study, the first and only clinical trial to establish pediatric safety and effectiveness of any HRIG in the U.S. \nAdditional evidence to support the use of KEDRAB in children comes from real world evidence. According to Centers for Disease Control and Prevention (CDC) data, no children in the U.S. treated with post-exposure prophylaxis have been reported to have had rabies between 2018 and April 2021. \nRabies is a life-threatening disease, but it is fully preventable if treated on time. It impacts approximately 40,000 people in the U.S. each year. According to the World Health Organization (WHO), up to 40 percent of people exposed to a suspected rabid animal are children under 15 years of age.\n\"Improving the lives of people with rare and serious diseases is our most important mission at Kedrion Biopharma,\" said Kedrion Biopharma Chief Executive Officer, Val Romberg. \"As the U.S. market's first and only human rabies immune globulin to be...