FDA accepts BLA for human anti-rabies lgG therapy

Kedrion Biopharma and Kamada's Biologics License Application for human anti-rabies immunoglobulin (lgG) therapy has been accepted for review by the U.S. Food and Drug Administration.
“The FDA’s review of this application is an encouraging step toward bringing to market a needed new treatment option for post-exposure prophylaxis of rabies,” Dr. Kedrion Biopharma, senior director of Medical Affairs Garrett Bergman, said. “Rabies is a completely preventable condition, and emergency room healthcare professionals and pharmacists, in particular, will welcome the arrival of an additional choice in providing urgent medical care to those who may have been exposed to this deadly virus.”
The Prescription Drug User Fee Act goal date for the BLA has been set for Aug. 29, 2017, by the FDA.
“The FDA’s acceptance of our BLA for review is a significant milestone for Kamada,” Kamada Chief Executive Officer Amir London said. “This is an indication with limited treatment options in the U.S. and we are confident that this therapy has the potential to gain meaningful market share in the U.S. over time. Kedrion has significant expertise in commercializing plasma-derived therapies and we look forward to continuing the successful collaboration between our companies.”