Cara Therapeutics: CHMP Recommends Approval Of Kapruvia

(RTTNews) - Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics, Inc. (CARA) announced that the European Medicines Agency's CHMP has recommended approval of Kapruvia for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients. The companies noted that, if approved, Kapruvia will be the first therapy available in Europe for the treatment of chronic kidney disease-associated pruritus in hemodialysis patients.

The positive CHMP opinion is based on pivotal clinical data from two phase-III trials, KALM-1 and KALM-2, and supportive data from an additional 32 clinical studies. European Commission decision for marketing authorization is anticipated in the second quarter of 2022.