FDA green lights Korsuva for pruritus in hemodialysis patients

24 August 2021

The US Food and Drug Administration has approved Korsuva (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis, said Cara Therapeutics (Nasdaq: CARA), whose shares shot up almost 29% to $18.38 in pre-market trading this morning.

Korsuva injection, which is partnered with Swiss drugmaker Vifor Pharma (VTX: VIFN), is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system. Some analysts have forecast that Korsuva could potentially bring in over $500 million sales at peak.

“The FDA approval of Korsuva injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult hemodialysis patients suffering from moderate-to-severe pruritus,” said Derek Chalmers, president and chief executive of Cara Therapeutics. “We look forward to working closely with our commercial partner, Vifor Pharma, to launch Korsuva injection in the US in the coming months.

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