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2021-08-26| Trials & Approvals

FDA Approves Cara & Vifor’s CKD-Associated Pruritus Injection

by Judy Ya-Hsuan Lin
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FILE - This Oct. 14, 2015, file photo shows the Food and Drug Administration campus in Silver Spring, Md. The FDA on Monday, Sept. 19, 2016, granted tentative approval to the first drug for muscular dystrophy, following an intense public campaign from patients and doctors who pushed for the largely unproven medication. The FDA cleared Sarepta Therapeutics’ Exondys 51 for a rare form of Duchenne muscular dystrophy, a deadly inherited disease that affects boys. (AP Photo/Andrew Harnik, File)

Pruritus affects many hemodialysis patients with chronic kidney disease, a condition known as CKD-associated Pruritus (CKD-aP). Studies estimate a 40% CKD-aP prevalence in patients with end-stage renal disease (ESRD), with about 25% of them reporting severe pruritus.

Recent data from the ITCH National Registry Study shows that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Currently available medications, such as antihistamines and corticosteroid, are unable to relieve the itch symptoms, leading to reduced quality of life and causing depression among patients.

On August 24th, the FDA approved Korsuva (difelikefalin) injection, a kappa opioid receptor agonist developed by Cara Therapeutics for the treatment of moderate-to-severe pruritus in hemodialysis patients. The approval is based upon the positive data from two critical Phase 3 trials, KALM-1 conducted in the US, and KALM-2 conducted globally.

“The FDA approval of KORSUVA™ injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult hemodialysis patients suffering from moderate-to-severe pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and CEO of Cara Therapeutics.

“We look forward to working closely with our commercial partner, Vifor Pharma, to launch KORSUVA™ injection in the U.S. in the coming months. We extend our deepest gratitude to the patients who participated in our KALM-1 and KALM-2 clinical trials, the study investigators, and especially our employees, as their commitment through over 10 years of collective effort made this important milestone possible.”

After failing a Phase 2 trial for Korsuva in atopic dermatitis earlier in April, and a pain study for osteoarthritis in 2017, this FDA approval would give some solace to Cara.

 

Financial Wins After FDA Approval

The partnership between Cara Therapeutics and Vifor Pharma grants each an exclusive license in the US. Unlike a previous equal share agreement in Fresenius Medical Care clinics in the US, a 60:40 profit-sharing arrangement in non-Fresenius Medical Care clinics has Cara earning slightly more than Vifor. The news led to the surge of Cara’s shares by 29% in pre-market trading on Tuesday.

“We are very excited about the FDA approval of KORSUVA™ injection,” said Abbas Hussain, CEO of Vifor Pharma. “There is a significant unmet medical need for a targeted therapy, and we believe that KORSUVA™ injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis. We are committed to bringing this first-in-class medicine to U.S. hemodialysis patients as fast as possible, together with our partner Cara Therapeutics.”

“We are pleased to see that KORSUVA™ injection has received FDA approval as the first treatment option approved for moderate to severe pruritus in adult CKD patients on hemodialysis,” commented Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care.

“Participating in the robust clinical trial program we have learned that KORSUVA™ injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch.”

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