Cara Therapeutics, Inc. (NASDAQ: CARA) and Vifor Pharma disclosed Monday that US FDA has recognized and awarded Priority Review for the NDA for KORSUVA solution for the cure of mild-to-serious pruritus in hemodialysis sufferers. FDA has arranged the Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021.
Furthermore, FDA disclosed that it has not yet decided to hold the meeting regarding the discussion on the application. The FDA has awarded Priority Review to drug applications for a possible cure. It is anticipated that if this cure will gain approval it would be substantial enhancements in the safety or efficacy of the therapy, diagnosis, or avoidance of severe conditions when compared to the basic applications.
The submission of NDA is backed by the encouraging data from the two pivotal Phase 3 trials KALM-1, carried out in the U.S. This acceptance of NDA is a great accomplishment for the firm, and this is the ray of hope for hemodialysis patients with chronic intractable pruritus.
Vifor Pharma Group revealed that this is a significant milestone as FDA has awarded Priority Review to the advanced therapy. All around the globe, nearly 40% of sufferers are experiencing this disease. This new treatment is compatible with the vision of the firm to offer a sophisticated cure to sufferers who are experiencing serious diseases. Both the firms are striving to bring this new treatment to the US.