Many chronic kidney disease patients undergoing hemodialysis experience severe itching later. The exact cause of this so-called pruritus is unclear, but it can significantly reduce the quality of life.Patients now have their first FDA approved Therapy, an injectable drug developed by Cara Therapeutics.
The FDA’s decision cleared the way for the drug difelikefalin to treat adults on dialysis with moderate to severe itching. Cara, headquartered in Stamford, Connecticut, will commercialize its new drug under the name “Korsuva.”
according to National Kidney FoundationIn the United States, more than 500,000 people receive dialysis to replace kidney function. It is estimated that 60% of them have itching; Eric Vandal, the company’s senior vice president of business, said on a conference call that 40% of dialysis patients are moderate to severe.
Pruritus is traditionally controlled by steroids, antihistamines, and other off-label medications. Korsuva is a peptide that targets κ opioid receptors on the peripheral nervous system and immune cells. Cara stated in its regulatory filings that these receptors regulate the release of substances that cause itching. The drug does not target μ opioid receptors, which can cause euphoria that can lead to addiction.
The FDA’s approval of Korsuva is based on the results of two placebo-controlled Phase 3 studies. Taken together, these studies evaluated the medications of 424 patients taking 3 times a week and 424 subjects taking placebo. The main goal is to measure changes based on a scale used to assess the severity of itching. In the first trial, 40% of patients in the treatment group reported an improvement of 4 points or higher in the pruritus score, compared with 21% in the placebo group. In Trial 2, 37% of people taking Cara’s drug achieved a score of 4 or higher, while 26% of those taking a placebo achieved a score of 4 or higher.
The patient tolerated Korsuva well. The most common adverse reactions include diarrhea, dizziness, nausea, headache and drowsiness. Although the drug targets an opioid receptor, it is not a predetermined substance. According to the prescription information, Korsuva is injected into the intravenous line of the dialysis circuit at the end of each hemodialysis treatment. Cara will work with Vifor Pharma to commercialize Korsuva.
For many years, pruritus has been an elusive drug target. This started to change. last month, Albireo Pharma’s Bylvay received FDA approval. This is a small molecule drug and the first drug approved for the treatment of pruritus in patients with congenital familial intrahepatic cholestasis, A rare inherited liver disease.
The Carla pipeline is still oriented towards Corsuva. The injectable version is currently being reviewed as a potential treatment for acute postoperative pain and postoperative nausea and vomiting. At the same time, the company is also evaluating the oral version of the drug in a separate phase 2 study of chronic kidney disease-related pruritus; primary biliary cholangitis of liver disease; paresthesia, a neurological disease that causes itchy skin on the upper back.
Not all of Kara’s efforts have been successful. In April, the company reported oral Korsuva Failure Phase 2 study of itching associated with skin disease atopic dermatitis.
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