Otsuka Canada Pharmaceutical Inc. announces Health Canada approval of KORSUVA® (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients

• First and only therapy approved by Health Canada for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
• Launch of KORSUVA in Canada is expected in the second quarter of 2023

MONTREAL, Aug. 16, 2022 /CNW/ - Otsuka Canada Pharmaceutical Inc. (OCPI) today announced that Health Canada has approved KORSUVA (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.¹ KORSUVA is a first-in-class kappa opioid receptor (KOR) agonist that targets the body's peripheral nervous system. CKD associated pruritus affects an estimated 16,000 Canadians with end-stage renal disease on hemodialysis.^2,3

"Chronic kidney disease is a debilitating and life-threatening disease that is vastly underdiagnosed," said Elizabeth Myles, National Executive Director of The Kidney Foundation of Canada. "It's encouraging that new treatment options are being approved for patients with chronic kidney disease –"

Dr. Claudio Rigatto, nephrologist, commented "CKD-aP is a common but under-recognized and under-treated condition, and one of the top 3 priorities identified by hemodialysis patients for further research and innovation. Therefore, it is really great to see a new treatment approved in Canada with the potential to improve the lives of many patients suffering from CKD-aP, that is supported by robust KALM 1&2 randomized clinical trials to demonstrate difelikefalin's efficacy and safety." 

"We are very proud to be bringing this new treatment option to Canadian patients. The availability of a first in class treatment for this condition, is highly anticipated in Canada as it represents an important advancement that will address clinical care gaps" – Michael Laranjo, president and general manager of OCPI. 

The approval of KORSUVA is based on pivotal clinical data from two phase-III trials, KALM-1⁴ and KALM-2^5,6, as well as supportive data from an additional 32 clinical studies. These studies showed that treatment with KORSUVA resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life components and was found to be generally well tolerated in patients with moderate-to-severe CKD-associated pruritus.

In April of 2021, OCPI secured exclusive rights from Vifor Fresenius Medical Care Renal Pharma to promote and distribute KORSUVA in Canada. OCPI expects to launch KORSUVA in Canada in the second quarter of 2023 upon supply availability. KORSUVA, developed by Cara Therapeutics, is also approved in the United States, as well as in the European Union and Great Britain under the brand name Kapruvia^®. 

About Otsuka Canada 

OCPI is an innovative, fast-growing health care company that commercializes novel medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardio-renal, and nephrology. OCPI was established in 2010, with headquarters in Saint-Laurent, Quebec.  

OCPI is part of Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: "Otsuka – people   creating   new   products   for better   health   worldwide." Otsuka Pharmaceutical Co., Ltd., researches, develops, manufactures, and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. 

Otsuka Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employs approximately 47,000 people worldwide and had consolidated sales of approximately USD 13.6 billion in 2021. 

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka on our global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Canada at www.otsukacanada.com. 

KORSUVA is a registered trademark of Cara Therapeutics used under license by OCPI.

About Chronic Kidney Disease-associated Pruritus (CKD-aP)

Chronic Kidney Disease-associated Pruritus (CKD-aP) is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.^3,7,8 Recent data from the ITCH National Registry Study showed that, among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.⁹ CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.

References:  

^1	Product Monograph, August 12, 2022,  Korsuva ( difelikefalin) indication:
^2	Canadian Institute for Health Information. Treatment of End-Stage Organ Failure in Canada, Canadian Organ Replacement Register, 2011 to 2020: End-Stage Kidney Disease and Kidney Transplants — Data Tables. Ottawa, ON: CIHI; 2021
^3	Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.
^4	Fishbane S, et al. A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus. N Engl J Med 2020;382:222-32
^5	Topf J, et al. Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Q1 Q2 Analysis of KALM-1 and KALM-2 Phase 3 Studies. Kidney Med (Article in Press) 2022
^6	Fishbane S, et al. Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Q1 Pooled Analysis From the Phase 3 Clinical Trial Program. Kidney Med (Article in Press) 2022
^7	Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.
^8	Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505
^9	Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.

SOURCE Otsuka Canada Pharmaceutical Inc.

Milena Bembic, Vice-President Legal Affairs and Compliance, 514-332-3175, [email protected]