Pruritus Risk Factors in Nondialysis CKD Identified
A recent study found that moderate to severe pruritus developed in 34% of patients with chronic kidney disease who are not dialysis.
A recent study found that moderate to severe pruritus developed in 34% of patients with chronic kidney disease who are not dialysis.
Clinical improvement in pruritus itch intensity occurs in fewer weeks than previously reported.
In a previous US phase 2 trial, no clear dose response was observed with difelikefalin.
In cohort of individuals with diabetes, no association seen for chronic kidney disease stage 3 to 5 with atopic eczema, psoriasis
The approval was based on data from the pivotal phase 3 KALM-1 and KALM-2 trials, as well as data from an additional 32 clinical studies.
The NDA submission is supported by data from the pivotal phase 3 KALM-1 and KALM-2 trials.