Korsuva filed with FDA and given priority review in pruritus in hemodialysis patients.- Vifor Pharma and Cara Therapeutics

Vifor Pharma and Cara Therapeutics announced that the FDA has accepted and granted Priority Review for the New Drug Application (NDA) for Korsuva (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for Korsuva is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.The NDA filing is supported by positive data from two pivotal phase-III trials KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232) and the global KALM-2, as well as supportive data from an additional 32 clinical studies. Comment: Pruritus in hemodialysis patients is a debilitating condition with a significant impact on quality of life and increased risk for hospitalization and mortality. It impacts up to 40% of dialysis patients around the world.