FDA Approves Cara Therapeutics,’ Vifor Pharma’s Itching Drug for CKD

Cara Therapeutics and Vifor Pharma have won FDA approval for injectable Korsuva (difelikefalin) for treating moderate-to-severe pruritus, or itching, linked with chronic kidney disease (CKD) in adults undergoing dialysis — the first such approved treatment in the U.S.

The approval was supported by positive data from two late-stage trials in which Korsuva was shown to reduce itching against placebo, as well as results from 32 additional trials, with the new drug application given a Priority Review by the FDA.

Vifor Pharma and Cara Therapeutics said they are currently negotiating with the Centers for Medicare and Medicaid Services to offer Korsuva and plan to launch the drug during the first quarter of next year.