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  • Korsuva filed with FDA for treating moderate-to-se...

Korsuva filed with FDA for treating moderate-to-severe pruritus in hemodialysis patients.- Cara Therapeutics

Read time: 1 mins
Published:29th Dec 2020
Cara Therapeutics announced that it has submitted a New Drug Application (NDA) to the FDA for Korsuva Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients. Korsuva Injection received Breakthrough Therapy Designation from the FDA for this indication. Cara has requested Priority Review for the NDA which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. The NDA submission is supported by positive data from two pivotal Phase III trials of Korsuva Injection, including the KALM-1 trial conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232) and the global KALM-2 trial, as well as supportive data from an additional 32 clinical studies.See: "A Phase III Trial of Difelikefalin in Hemodialysis Patients with Pruritus." Steven Fishbane et al. N Engl J Med 2020; 382:222-232 DOI: 10.1056/NEJMoa1912770
Condition: Uremic Pruritus + Dialysis
Type: drug

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