Korsuva accepted for FDA priority review in pruritis

8 March 2021

Swiss drugmaker Vifor Pharma (VTX: VIFN) and Cara Therapeutics (Nasdaq: CARA) today announced that the US Food and Drug Administration has accepted and granted Priority Review for the New Drug Application (NDA) for Korsuva (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients.

The Prescription Drug User Fee Act (PDUFA) target action date for Korsuva is August 23, 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.

Vifor and Cara entered into a collaboration on Korsuva in October 2020, under which the US firm receive an upfront payment of $100 million in cash and an equity investment of $50 million and eligibility for a total of $290 million. Vifor’s shares were up 3.8% at 121.35 Swiss francs by mid-morning.

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