Chronic kidney disease-related itching (CKD-aP) breakthrough drug! Korsuva (difelikefalin), an opioid-infested (KOR) excitant, is on the market!

December 28, 2020 // -- Cara Therapeutics is a clinical biopharmaceutical company focused on developing and commercializing new chemicals designed to relieve itching by selectively targeting exosome opioids (KOR).
recently, the company announced that it had submitted a new drug application (NDA) for Korsuva (CR845, difelikefalin) injections to the U.S. Food and Drug Administration (FDA) to treat moderate to severe itching in patients with hemodialysis.
, the FDA has granted Korsuva a breakthrough drug (BTD) to treat the allergy.
Cara Therapeutics has asked the FDA to conduct a priority review of the NDA, which, if approved, would be four months shorter than the regular review.
chronic kidney disease-related itching (CKD-aP) is a disease that occurs in patients with chronic kidney disease receiving hemodialysis, with itching occurring in many dialysis patients (60-70%) and 30-40% of cases reported to be moderate or severe.
Korsuva's active drug ingredient is diefelikefalin, a pioneering (first-in-class) KOR excitant that actes on the peripheral nervous system and certain immune cells.
difelikefalin Chemical Structure (Photo: medkoo.com) This NDA is based on positive data from two key Phase 3 clinical trials, including the KALM-1 trial in the United States and the global KALM-2 trial, as well as support data from 32 additional clinical studies.
in Phase 3 clinical trials, hemodialysis patients with moderate to severe CKD-aP showed significant statistically significant improvements in itching intensity and quality of life after treatment with Korsuva injections.
Derek Chalmers, President and CEO of Cara Therapeutics, said, "The submission of the Korsuva injection NDA marks an important milestone for Cara and patients with hemodialysis with persistent itching.
I would like to thank the entire Cara team for their tireless efforts, from in-house discovery to development, to completion of NDA submissions, as well as to patients, researchers and field personnel involved in clinical trials.
we look forward to working with the FDA during the review process and with our commercial partner Vifor Pharma to continue to focus on the preparations for the U.S. launch of Korsuva injections.
"Chronic kidney disease-related itching (CKD-aP, pictured: DermNet NZ) Chronic renal disease-related itching (CKD-aP) is a resoicable systemic itching disease that occurs frequently and with high intensity in patients with chronic kidney disease on dialysis.
also reported itching in patients with stage III-V CKD without dialysis.
, longitudinal and multi-country studies estimate that the weighted prevalence of CKD-aP in end-stage renal disease (ESRD) patients is about 40%, and about 25% of patients report severe itching.
most dialysis patients (about 60 to 70 percent) reported itching, of which 30 to 40 percent reported moderate or severe itching.
latest data from ITCH National Registry Study shows that about 59 percent of itchy patients develop symptoms every day or almost daily for more than a year.
Given its relationship with CKD/ESRD, most patients will experience symptoms that last for months or years, and the itchkillers currently in use, such as antihistamines and corticosteroids, do not provide consistent and adequate relief.
severe chronic itching has repeatedly been shown to directly reduce quality of life, leading to symptoms that impair quality of life (e.g. poor sleep quality) and is associated with depression.
CKD-aP is also an independent predictor of mortality in hemodialysis patients, mainly associated with increased risk of inflammation and infection.
() Origin: Cara Therapeutics Submits New Drug application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus