FDA grants Priority Review to Korsuva for CKD-associated pruritis

pharmafile | March 8, 2021 | News story | Sales and Marketing Cara Therapeutics, FDA, Korsuva 

The FDA has accepted and granted Priority Review for the new drug application (NDA) for Cara Therapeutics’ Korsuva (difelikefalin) solution for injection for the treatment of moderate-to-severe chronic kidney disease associated pruritus (CKD-aP) in haemodialysis patients.

CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis.

Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life, and is associated with depression.

CKD-aP is also an independent predictor of mortality among haemodialysis patients, mainly related to increased risk of inflammation and infections.

The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

The NDA filing for Korsuva is supported by positive data from two pivotal Phase III trials – KALM-1, conducted in the US, and the global KALM-2 – as well as supportive data from an additional 32 clinical studies.

Derek Chalmers, President and Chief Executive Officer of Cara Therapeutics, said: “The FDA acceptance for filing and granting of Priority Review for the Korsuva NDA marks a significant milestone for Cara and for the substantial number of haemodialysis patients with chronic intractable pruritus.

“The FDA’s agreement to expedite the timeline through Priority Review designation aligns with our understanding of the therapeutic potential of Korsuva to fundamentally change the treatment paradigm for this serious unmet need.

“We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain focused on preparing for the US launch of Korsuva injection, if approved.”

Darcy Jimenez

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