Cara Therapeutics (NASDAQ:CARA) has submitted a New Drug Application to the US FDA for KORSUVA™ Injection for treating moderate-severe pruritus in hemodialysis. Already KORSUVA has Breakthrough Therapy Designation for pruritus treatment in hemodialysis patients.
Cara submits NDA for KORSUVA Injection
The company requested Priority Review for the NDA, which if successful will mean a six-month review process. The US FDA has a 60-day filing review to establish if the NDA is complete and okay for filing. The company supported the NDA filing with positive data from pivotal Phase 3 KORSUVA Injection Studies that included the KALM-1 study conducted in the US and the global KALM-2 study.
Cara’s CEO and President Derek Chalmers said the NDA submission for KORSUVA Injection is a huge milestone for the company as well as for hemodialysis patients struggling with intractable pruritus. Derek thanks the Cara team for its efforts to deliver the first-in-class therapeutic for discovery through to development and NDA submission. He added that they are looking forward to the FDA’s review process and the company is prepared for the KORSUVA Injection launch once approved.
Cara pays milestone payment to Enteris
The company recently paid a $2.5 million milestone payment to SWK Holdings Corp’s (NASDAQ:SWKH) subsidiary Enteris BioPharma related to the license agreement for Peptelligence® oral formulation tech used in Oral KORSIUVA™. The oral formulation is Cara’s first-in-class KOR agonist. The milestone payment comes at the back of another payment of $2.5 million that Cara made in October.
Cara engineered Oral KORUSVA through Enteris’ Peptelligence tech that is designed to allow oral delivery of peptides as well as BCS small Molecules. Currently, Oral KORSUVA is being evaluated in their separate late-stage clinical studies in patients having pruritus with hepatic impairment because of [primary biliary cholangitis, atopic dermatitis, and stage III/IV chronic kidney disease. Cara reported encouraging top-line data in December 2019 from the Phase 2 Oral KORSUVA clinical study for pruritus treatment in patients with stage II/IV CKD. The company plans to complete an end-of-phase 2 meeting with the FDA in Q1 2021.