FDA Approves IV Tx for Dialysis Related Puritus – Korsuva

The FDA recently approved Cara Therapeutics’s infused drug, Korsuva (difelikefalin), to treat puritus (moderate-to-severe itching) in patients with chronic kidney disease (CKD) undergoing dialysis. It is the first targeted therapy to effectively treat the condition in the United States. Korsuva will be commercialized jointly by Cara and Vifor Pharma.

Korsuva is administered 3X weekly following dialysis. Korsuva reduces sensory nerve response that relays itching from the skin to the brain. Many chronic kidney disease CKD patients with persistent itching currently take depressants, barbiturates, or allergy medications / antihistamines with limited relief.

Cara said that Korsuva will be priced at ~ $17,000 annually. Analyst estimates suggest that Korsuva will garner about $100 million 2022 and grow to about $250 million within the next five years.

Product launch is scheduled for the first quarter of 2022. Details related to distribution were not released. Given the relatively small patient forecast and the site of administration (dialysis clinics) it is likely that Korsuva will be available through traditional distributor channels.


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