FDA accepts and gives priority review for difelikefalin (KORSUVA™) injection in haemodialysis patients with moderate-to-severe pruritus
This acceptance is following positive data from 2 phase-III trials KALM-1, conducted in the U.S and global KALM-2, as well as supportive data from additional 32 clinical studies. difelikefalin would be first therapy for treatment of pruritus in haemodialysis patients if approved.
Source:
Biospace Inc.