FMS - Cara Vifor's Kapruvia gets approval in Switzerland to treat itch in hemodialysis patients
- The Swiss Agency for Therapeutic Products (Swissmedic) approved Cara Therapeutics ( NASDAQ: CARA ) and Vifor Fresenius Medical Care Renal Pharma's Kapruvia (difelikefalin) to treat moderate-to-severe pruritus (itching) associated with chronic kidney disease in adult hemodialysis patients.
- The companies said Kapruvia is the first and only therapy approved through consortium filing for treating this particular condition in these patients.
- The approval was backed by data from two pivotal phase 3 trials – KALM-1, conducted in the U.S., and the global study, dubbed KALM-2 — plus supportive data from an additional 32 clinical studies.
- Kapruvia is approved in Canada under the name Korsuva.
- The companies expect regulatory decisions in Australia and Singapore by the end of 2022.
- Vifor Fresenius is a joint company of CSL ( OTCPK:CSLLY ) ( OTCPK:CMXHF ) and Fresenius Medical Care ( FMS ). CSL had acquired Vifor Pharma ( OTCPK:GNHAY ) in a ~$11.7B deal.
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Cara, Vifor's Kapruvia gets approval in Switzerland to treat itch in hemodialysis patients