Committee for Medicinal Products for Human Use recommends EU approval of Kapruvia for CKD
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The Committee for Medicinal Products for Human Use recommended approval of Kapruvia as the first therapy in Europe for chronic kidney disease-associated pruritus in patients on hemodialysis, according to a release.
Kapruvia (difelikefalin) will be the first therapy of its kind available in Europe if it gains European Union marketing authorization, according to the release. Vifor Fresenius Medical Care Renal Pharma partnered with Cara Therapeutics Inc. on the treatment and await a final decision from the European Commission in the second quarter of 2022.
“The positive Committee for Medicinal Products for Human Use (CHMP) recommendation is another major step forward on our mission to help kidney patients around the world lead better, healthier lives,” Klaus Henning Jensen, MBA, PhD, chief medical officer of Vifor Pharma, said in the release. “Kapruvia has demonstrated important clinical benefits to significantly relieve patients of the severe burden of chronic kidney disease-associated pruritus, a condition that has been historically underdiagnosed and undertreated. We look forward to the European Commission decision anticipated in [the second quarter of] 2022, and to bringing a therapy with the potential to advance treatment of chronic kidney disease-associated pruritus to patients in Europe.”
This announcement follows FDA approval of Korsuva (difelikefalin) in the U.S., which is intended to commercially launch in April 2022. If approved, Kapruvia will become available to all member states of the European Union, including Iceland, Lichtenstein and Norway.
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