By Dania Nadeem
(Reuters) -The Food and Drug Administration on Monday approved Cara Therapeutics’s drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making it the first U.S.-approved therapy for the ailment.
The company expects to commercially launch the drug, Korsuva injection, in the first quarter of 2022, Chief Executive Officer Derek Chalmers said in an interview.
The therapy is designed to be administered three times a week after each dialysis. It reduces the activity of the sensory nerve that relays itching from the skin to the spinal cord and subsequently to the brain.
Chronic kidney disease patients with severe itching currently take depressants such as barbiturates and allergy medication antihistamines.
Cara has an exclusive license agreement with Switzerland-based Vifor Pharma for the commercialization of its drug, under which Cara would earn 60% of the profit on U.S. sales.
Jefferies analyst Christopher Howerton estimates Korsuva will generate peak sales of about $900 million in 2030.
The company has also filed for marketing approval for the therapy with the European Medicines Agency, whose decision is due in the second quarter of 2022.
Cara is also developing an oral form of Korsuva in five different conditions, including atopic dermatitis.
(Reporting by Dania Nadeem and Manojna Maddipatla in Bengaluru; Editing by Aditya Soni)
