USA – The Food and Drug Administration has approved Cara Therapeutics’s drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making it the first therapy for the ailment in the United States.

The company expects to commercially launch the injection, Korsuva, in the first quarter of 2022, Chief Executive Officer Derek Chalmers said in an interview.

The drug 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.

The company has an exclusive license agreement with Switzerland-based Vifor Pharma for Korsuva, under which it would earn 60% of the profit on U.S. sales.

Cara said it could price the drug similar to the US$17,000 annual cost of Amgen treatment Parsabiv, which treats secondary hyperparathyroidism, or excessive secretion of parathyroid hormone, in kidney disease patients.

According to global data, the Kidney Disease global market is expected to reach US$133,444.71 million by 2027 from US$81,128.11millionin 2019; it is estimated to grow at a CAGR of 6.5% from 2020 to 2027.

Based on product type, the global kidney disease market is segmented into diagnosis and treatment. The diagnosis segment is estimated to register the highest CAGR in the market during the forecast period.

High prevalence of chronic diseases leading to kidney diseases and favorable reimbursement policy for the kidney disease treatments are the key factors driving the growth of the kidney disease market.

Moreover, increase in preference for robotic surgeries for kidney diseases is likely to have positive impact on the market in the coming years. However, undiagnosed cases of kidney disease are restricting the market growth.

Jefferies analyst Christopher Howerton estimates Korsuva will generate peak sales of about US$900 million in 2030.

Cara has also filed for marketing approval with the European Medicines Agency, whose decision is due in the second quarter of 2022. It is also developing an oral form of Korsuva in five different conditions, including atopic dermatitis.

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