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By Dania Nadeem
Aug 23 (Reuters) – The Food and Drug Administration on Monday approved Cara Therapeutics’ drug to treat moderate to severe itching in chronic kidney disease patients on dialysis, making it the first treatment for the disease in the States -United.
The company plans to commercially launch the injection, Korsuva, in the first quarter of 2022, chief executive Derek Chalmers said in an interview.
The medicine is designed to be given three times a week after each dialysis. It reduces the activity of the sensory nerve which transmits the itchy rash from the skin to the spinal cord and then to the brain.
Chronic kidney disease patients with severe itching are currently taking depressants such as barbiturates and anti-allergic antihistamines.
Cara’s shares were unchanged after the bell, gaining around 4% in regular trading on Monday.
The company has an exclusive licensing agreement with Switzerland-based Vifor Pharma for Korsuva, under which it would earn 60% of profits on sales in the United States.
Cara said the drug’s price could be similar to the $ 17,000 annual cost of Amgen Inc’s Parsabiv treatment, which treats secondary hyperparathyroidism, or excessive parathyroid hormone secretion, in patients with kidney failure. .
Jefferies analyst Christopher Howerton estimates that Korsuva will generate peak sales of around $ 900 million in 2030.
Cara has also submitted a marketing authorization application to the European Medicines Agency, whose decision is expected in the second quarter of 2022.
He 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)
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