Posted by Michael Wonder on 28 Aug 2017
Kedrion Biopharma and Kamada receive FDA approval of Kedrab for post-exposure prophylaxis against rabies infection
25 August 2017 - Approval of Kedrab is based on positive data from a prospective, randomised, double-blind, non-inferiority Phase 2/3 study of 118 healthy subjects, conducted in the U.S.
Kedrion Biopharma and Kamada today announced that Kedrab [rabies immune globulin (human)] has received U.S. FDA approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. Kedrab should be administered concurrently with a full course of rabies vaccine.
Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year, representing an annual market opportunity of $100 million-plus. Kedrab will launch in the U.S. in early 2018.
