Kapruvia® approved in Switzerland with additional regulatory decisions expected in H2 2022 | Your money

Kapruvia® (difelikefalin) is the first and only treatment approved through a consortium filing for the treatment of pruritus associated with chronic kidney disease (CKD) in hemodialysis patients

Therapy recently approved in Canada under the brand name KORSUVA®

Regulatory decisions in Australia and Singapore expected by end of 2022

ST. GALLEN, Switzerland, and STAMFORD, Conn., Aug. 19, 2022 (GLOBE NEWSWIRE) — Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that they have received approval for Kapruvia ® from the Swiss Institute for Therapeutic Products (Swissmedic). Kapruvia® will be the first therapy available for the treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients on hemodialysis. Swissmedic’s approval for Kapruvia® follows approvals from the US Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as Health Canada.

“The approval of Kapruvia® in Switzerland is the next step in our journey to bring this breakthrough treatment to hemodialysis patients living with CKD-associated pruritus worldwide,” said Dr. Klaus Henning Jensen, Chief Medical Officer of CSL Vifor. “There is a significant unmet medical need for a targeted therapy to treat moderate to severe pruritus, and we are confident that Kapruvia® can provide relief to many people suffering from this heavy burden. We are very committed to making this therapy available to patients as soon as possible. »

“We are delighted that Kapruvia® is now approved in Switzerland for hemodialysis patients with CKD-associated pruritus,” said Christopher Posner, President and CEO of Cara Therapeutics. “As Cara Therapeutics continues to become the leader in the treatment of chronic pruritus, we are working with our partner VFMCRP to ensure this first-of-its-kind therapy is available to healthcare providers and patients around the world who have badly needed a treatment option.

Swissmedic’s approval was supported by positive data from two pivotal Phase III trials – KALM-1, conducted in the US (New England Journal of Medicine 2020; 382:222-232), and the global KALM trial -2, along with supporting data from 32 additional clinical studies.

Kapruvia® has been filed in Switzerland under an Access Consortium procedure with Canada (approved in August 2022), as well as in Australia and Singapore. Regulatory decisions on these two markets are expected in the second half of 2022.

About CSL Vifor

CSL Vifor is a global partner of choice for innovative, cutting-edge pharmaceuticals and therapies in the areas of iron deficiency, dialysis, nephrology and rare diseases. We specialize in strategic global partnerships, licensing and development, manufacturing and marketing of precision healthcare pharmaceutical products, aimed at helping patients around the world lead better and healthier lives. . Based in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).

The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and provides its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor, visit www.cslvifor.com.

About Cara Therapeutic

Cara Therapeutics is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients with pruritus. The company’s new KORSUVA™ (difelikefalin) injection is the first and only FDA-approved treatment for moderate to severe pruritus associated with chronic kidney disease in adults on hemodialysis. The Company is developing an oral formulation of difelikefalin and has initiated Phase 3 programs for the treatment of pruritus in patients with non-dialysis-dependent advanced chronic renal failure and atopic dermatitis. The Company has completed the placebo-controlled phase of a Phase 2 proof-of-concept trial of oral difelikefalin for the treatment of moderate to severe pruritus in patients with notalgia paresthetica. A phase 2 proof-of-concept trial in patients with primary biliary cholangitis with moderate to severe pruritus is ongoing. For more information, visit www.CaraTherapeutics.com and follow the company on Twitter, LinkedIn and Instagram.

About Pruritus Associated with Chronic Kidney Disease

CKD-associated pruritus is a refractory systemic itching condition that occurs with high frequency and intensity in patients with chronic renal failure on dialysis. Pruritus has also been reported in patients with CKD stage III-V who are not on dialysis. The majority of dialysis patients (approximately 60-70%) report pruritus, with 30-40% reporting moderate or severe pruritus.1,2,3 Recent data from the ITCH National Registry Study showed that among of pruritus sufferers, approximately 59% experienced daily or nearly daily symptoms for more than a year. Given its association with CKD/IRT, most affected patients will continue to have symptoms for months or years, with currently used antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent and adequate relief. . Moderate to severe chronic pruritus has been repeatedly shown to directly decrease quality of life, contribute to quality-of-life-impairing symptoms (such as poor sleep quality), and be associated with depression.4 Pruritus associated with CRM is also an independent predictor of mortality and risk of hospitalization in hemodialysis patients.

Forward-Looking Statements Statements in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such forward-looking statements include statements regarding the potential regulatory approval of difelikefaline solution for injection and potential timeline for EMA review and approval of marketing authorization and potential of difelikefaline solution for injection as a treatment option for CKD-aP in patients dependent on dialysis. Because these statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by these forward-looking statements. The risks are described in more detail in Cara’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of Cara’s Quarterly Report on Form 10-Q for the three months ended September 30, 2021 and its other documents subsequently filed with or furnished to the securities. and exchange commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.

References:

1 Pisoni RL, et al. Pruritus in hemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol dial graft. 2006; 21:3495-3505.

2 Ramakrishnan K, et al. Clinical characteristics and outcomes of patients with end-stage renal disease with self-reported symptoms of pruritus. International Journal of Nephrology and Renovascular Diseases. 2014 ; 7:1-12.

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 Mathur VS, et al. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.

CSL Vifor Media Contact

Thomas Hutter

Mobile: +41 79 957 96 73

Email: [email protected]

Cara Therapeutic Contacts:

Media Contact

Annie Spinette

6 degrees

+1 973-768-2170

[email protected]

Contact Investor

Iris Francesconi, PhD

Therapeutic Cara

+1 203-406-3700

[email protected]

Comments are closed.