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News March 31, 2021 /bioon.
com" target="_blank">/ --Cara Therapeutics is a clinical-stage biopharmaceutical company focusing on the development and commercialization of new chemical substances aimed at alleviating itching by selectively targeting peripheral kappa opioid receptors (KOR).
Recently, the company and its partner Vifor Pharma jointly announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for Korsuva (CR845, difelikefalin) injection, which is used to treat chronic kidney disease-related itching in hemodialysis patients (CKD-aP).
EMA will review MAA through a centralized marketing authorization process and is expected to make a review decision in the second quarter of 2022.
bioon.com" target="_blank">/ --Cara Therapeutics is a clinical-stage biopharmaceutical company focusing on the development and commercialization of new chemical substances aimed at alleviating itching by selectively targeting peripheral kappa opioid receptors (KOR).
Recently, the company and its partner Vifor Pharma jointly announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for Korsuva (CR845, difelikefalin) injection, which is used to treat chronic kidney disease-related itching in hemodialysis patients (CKD-aP).
EMA will review MAA through a centralized marketing authorization process and is expected to make a review decision in the second quarter of 2022.
com" target="_blank">
Earlier this month, the US FDA accepted Korsuva's New Drug Application (NDA) for the treatment of CKD-aP in hemodialysis patients and granted priority review.
Previously, the FDA has granted Korsuva a breakthrough drug designation (BTD) for the treatment of this indication.
The FDA has designated the "Prescription Drug User Fees Act" (PDUFA) target date as August 23, 2021.
bioon.
com/fda/" target="_blank">The FDA stated that it currently does not plan to convene an advisory committee bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">meeting to discuss the application.
bioon.Previously, the FDA has granted Korsuva a breakthrough drug designation (BTD) for the treatment of this indication.
The FDA has designated the "Prescription Drug User Fees Act" (PDUFA) target date as August 23, 2021.
bioon.
com/fda/" target="_blank">The FDA stated that it currently does not plan to convene an advisory committee bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">meeting to discuss the application.
com/fda/" target="_blank">FDA bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">meeting
If approved, Korsuva will be the first drug to treat chronic kidney disease-related pruritus (CKD-aP) in hemodialysis patients.
Korsuva will be the first drug to treat chronic kidney disease-related pruritus (CKD-aP) in hemodialysis patients.Chronic kidney disease-associated pruritus (CKD-aP) is a disease that occurs in patients with chronic kidney disease undergoing hemodialysis.
Many dialysis patients (60-70%) experience pruritus, and 30-40% of cases are reported as moderate Or severe.
Many dialysis patients (60-70%) experience pruritus, and 30-40% of cases are reported as moderate Or severe.
The active pharmaceutical ingredient of Korsuva is difelikefalin, which is a first-in-class KOR agonist that acts on the human peripheral nervous system and certain immune cells.
The chemical structure of difelikefalin (picture source: medkoo.
com)
com)
Both Korsuva MAA and NDA are based on positive data from two key Phase 3 clinical trials, including the KALM-1 trial and the global KALM-2 trial conducted in the United States, as well as supporting data from 32 additional clinical studies.
In phase 3 bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials , hemodialysis patients with moderate to severe CKD-aP, after receiving Korsuva injection, showed statistically significant improvements in the intensity of itching and quality of life indicators.
bioon. In phase 3 bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials , hemodialysis patients with moderate to severe CKD-aP, after receiving Korsuva injection, showed statistically significant improvements in the intensity of itching and quality of life indicators.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials
Dr.
Derek Chalmers, President and CEO of Cara Therapeutics, said: "The EMA's acceptance of Korsuva's regulatory application marks another important milestone for us.
We look forward to bringing this kind of innovation to hemodialysis patients worldwide with chronic intractable pruritus.
(First-in-class) therapy, Korsuva has the potential to fundamentally change the treatment model for this severe unmet need.
We look forward to working with EMA during the review process and continuing to focus with our business partner Vifor Pharma To prepare for the launch of Korsuva injections throughout Europe.
"
Derek Chalmers, President and CEO of Cara Therapeutics, said: "The EMA's acceptance of Korsuva's regulatory application marks another important milestone for us.
We look forward to bringing this kind of innovation to hemodialysis patients worldwide with chronic intractable pruritus.
(First-in-class) therapy, Korsuva has the potential to fundamentally change the treatment model for this severe unmet need.
We look forward to working with EMA during the review process and continuing to focus with our business partner Vifor Pharma To prepare for the launch of Korsuva injections throughout Europe.
"
Chronic kidney disease-related pruritus (CKD-aP, image source: DermNet NZ)
Chronic kidney disease-associated pruritus (CKD-aP) is a refractory whole body pruritus, which occurs frequently and intensely in patients with chronic kidney disease undergoing dialysis.
Itching has also been reported in patients with stage III-V CKD without dialysis.
Comprehensive, longitudinal, and multinational studies estimate that the weighted prevalence of CKD-aP in patients with end-stage renal disease (ESRD) is about 40%, and about 25% of patients report severe itching.
Itching has also been reported in patients with stage III-V CKD without dialysis.
Comprehensive, longitudinal, and multinational studies estimate that the weighted prevalence of CKD-aP in patients with end-stage renal disease (ESRD) is about 40%, and about 25% of patients report severe itching.
Most dialysis patients (approximately 60% to 70%) report pruritus, of which 30% to 40% report moderate or severe pruritus.
The latest data from the ITCH National Registry Study (ITCH National Registry Study) shows that among patients with itching, about 59% of patients will have symptoms every day or almost every day for more than one year.
In view of its relationship with CKD/ESRD, most patients will have symptoms that last for months or years, and current antipruritic drugs, such as antihistamines and corticosteroids, cannot provide consistent and adequate relief.
Moderate to severe chronic pruritus has repeatedly been shown to directly reduce quality of life, cause symptoms that impair quality of life (such as poor sleep quality), and are associated with depression.
CKD-aP is also an independent predictor of mortality in hemodialysis patients, which is mainly related to the increased risk of inflammation and infection.
()
The latest data from the ITCH National Registry Study (ITCH National Registry Study) shows that among patients with itching, about 59% of patients will have symptoms every day or almost every day for more than one year.
In view of its relationship with CKD/ESRD, most patients will have symptoms that last for months or years, and current antipruritic drugs, such as antihistamines and corticosteroids, cannot provide consistent and adequate relief.
Moderate to severe chronic pruritus has repeatedly been shown to directly reduce quality of life, cause symptoms that impair quality of life (such as poor sleep quality), and are associated with depression.
CKD-aP is also an independent predictor of mortality in hemodialysis patients, which is mainly related to the increased risk of inflammation and infection.
()
Original source: VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization app lication for difelikefalin
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