▎ WuXi AppTec content team editor
Cara Therapeutics company today announced that it has submitted a New Drug Application (NDA) for Korsuva (difelikefalin) injection to the US FDA for the treatment of severe itching in hemodialysis patients. Korsuva is a small molecule inhibitor that selectively targets peripheral kappa opioid receptors (KORs). It has received breakthrough therapy designation granted by the FDA. Cara has requested a priority review of this NDA. If approved, the review time can be shortened to 6 months.
Chronic kidney disease-associated pruritus (CKD-aP) is a refractory, generalized pruritus, which mostly occurs in CKD patients undergoing hemodialysis and peritoneal dialysis. Patients with stage III-V CKD who have not received dialysis treatment also have pruritus. Comprehensive longitudinal multi-country studies, it is estimated that about 60%-70% of dialysis patients will develop pruritus, of which 30% to 40% have moderate to severe pruritus. The main treatment options currently used for these patients to relieve itching, such as antihistamines and corticosteroids, do not provide consistent adequate relief. Moderate to severe chronic itching can directly affect the quality of life of patients, such as poor sleep quality, and may even lead to depression.
Korsuva is a highly selective peripheral kappa opioid receptor agonist. It has potent analgesic, anti-inflammatory and anti-pruritic effects in both humans and animals. Because Korsuva performs poorly at penetrating the blood-brain barrier, it produces little or no central nervous system (CNS)-mediated side effects such as nausea, vomiting, sedation, respiratory depression, abuse, addiction, or euphoria.
▲The molecular structure of Difelikefalin (picture source: Ed (Edgar181), Public domain, via Wikimedia Commons) The NDA submission of
was supported by positive data from two key phase 3 clinical trials, including KALM-1 in the United States Supporting data from trials and the global KALM-2 trial, as well as another 32 clinical studies.
In the randomized, double-blind, placebo-containing control group phase 3 clinical trial KALM-2, in the 12th week of treatment, the treatment group had 54% patients on the 24-hour daily digital rating scale for itching intensity (WI -NRS) score decreased by 3 points or more, and the proportion of patients in the placebo group who reached this level was 42%, reaching the primary endpoint of the trial. In addition, the WI-NRS score of 41% patients in the treatment group improved by 4 points or more compared with baseline, and the proportion of patients who reached this level in the placebo group was only 28%, reaching the key secondary endpoint of the trial .
"The submission of the NDA for Korsuva injection is an important milestone for hemodialysis patients suffering from intractable pruritus." said Dr. Derek Chalmers, President and CEO of Cara Therapeutics, "We look forward to continuing cooperation with the FDA during the review process. If approved, we will work with our business partner Vifor Pharma to continue to focus on preparing for the launch of Korsuva injection."
Note: This article is intended to introduce medical health research, not a treatment plan recommendation. If you need guidance on treatment plans, please go to a regular hospital for treatment.
Reference:
[1] Cara Therapeutics Submits New Drug Application to US Food and Drug Administration for KORSUVA Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus. Retrieved December 28, 2020, from http://ir.caratherapeutics.com /news-releases/news-release-details/cara-therapeutics-submits-new-drug-application-us-food-and-drug
Copyright notice: This article comes from the WuXi AppTec content team. Individuals are welcome to forward it to Moments. Media or institutions are not allowed to reprint it on other platforms in any form without authorization. For reprint authorization, please reply to "Reprint" on the WeChat official account of WuXi AppTec to obtain the reprint instructions.
