US clears Cara, Vifor's Korsuva to treat itching in CKD patients

Cara Therapeutics and Vifor Pharma said Monday that the FDA has approved Korsuva (difelikefalin) to treat moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing haemodialysis. The decision makes the KOR agonist, which targets the body's peripheral nervous system, the first treatment cleared in the US for this indication.

The filing, granted a priority review by the FDA earlier this year, was supported by results from the Phase III KALM-1 and KALM-2 trials comparing Korsuva against placebo. Both met their primary endpoints, with a greater proportion of Korsuva-treated patients achieving at least a three‑point improvement from baseline in the weekly mean of the daily 24‑hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at week 12. The FDA application was also backed by supportive data from an additional 32 clinical studies.

Launch early next year

Derek Chalmers, chief executive at Cara, said "we look forward to working closely with our commercial partner…to launch Korsuva injection in the US in the coming months." Cara and Vifor said they are in the process of submitting required documents to the US Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access. Vifor plans to begin promoting the treatment in the first quarter of 2022, with reimbursement expected in the first half of next year, subject to CMS timelines.

The drug, also known as CR845, is currently under review by the European Medicines Agency, with a decision there expected in the second quarter of 2022.

The companies have agreed to an exclusive license to sell Korsuva in the US through a 60-40 profit-sharing arrangement for Cara and Vifor, respectively, in non-Fresenius Medical Care clinics in the country. Under a previous deal, Vifor Fresenius Medical Care Renal Pharma and Cara had agreed to market Korsuva to Fresenius Medical Care North America dialysis clinics in the US under a 50-50 profit-sharing arrangement.