Full Press Release Details
Stamford, Conn. and St. Gallen, Switzerland, 23 August 2021
- Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved
KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in
adults undergoing hemodialysis . KORSUVA injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body's
peripheral nervous system. The KORSUVA injection new drug application (NDA) received Priority Review by the FDA, which is granted
to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention
of serious conditions when compared to standard applications.
"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 Chief Executive Officer 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."
"We are very excited about the FDA approval of KORSUVA
injection," said Abbas Hussain, Chief Executive Officer 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."
This approval is based on the New Drug Application filing that was
supported by positive data from two pivotal Phase 3 trials - KALM-1, conducted in the U.S. (New England Journal of Medicine 2020;
382:222-232), and the global KALM-2, as well as supportive data from an additional 32 clinical studies.KORSUVA injection was found
to be generally well tolerated.
Vifor Pharma and Cara have agreed to an exclusive license to commercialize
KORSUVA in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius
Medical Care clinics in the U.S. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and
Cara Therapeutics have agreed to market KORSUVA injection to Fresenius Medical Care North America
dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement.
Vifor Pharma and Cara Therapeutics are in the process of submitting
the required documentation to the U.S. Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access
to KORSUVA injection. Vifor Pharma expects to begin promoting KORSUVA Injection in Q1 2022 with reimbursement expected in
H1 2022, subject to CMS timelines.
Cara management will host a conference call today at 5:00 p.m. ET to
discuss the approval of KORSUVA injection for the treatment of moderate-to-severe pruritus in hemodialysis patients.
To participate in the conference call, please dial (855) 445-2816 (domestic)
or (484) 756-4300 (international) and refer to conference ID 1485906. A live webcast of the call can be accessed under "Events &
Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com.
An archived webcast recording will be available on the Cara website
beginning approximately two hours after the call.
Contacts and further information:
| Media Contact | Investor Contact | |
| Claire LaCagnina | Janhavi Mohite | |
| 6 Degrees | Stern Investor Relations, Inc. | |
| 315-765-1462 | 212-363-1200 | |
| clacagnina@6degreespr.com | janhavi.mohite@sternir.com |
Vifor Pharma contacts:
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company focused
on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid
receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA (CR845/difelikefalin),
a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In two Phase 3
trials, KORSUVA injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality
of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Oral KORSUVA has
completed Phase 2 trials for the treatment of pruritus in patients with CKD and atopic dermatitis and is currently in Phase 2 trials in
primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus.
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to
become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals
and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases
lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor
Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor
Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland,
and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com
About KORSUVA Injection
KORSUVA is a kappa opioid receptor agonist developed in Cara laboratories
and indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
(HD). KORSUVA Injection is not a federally controlled substance.
Breakthrough Therapy Designation was received from the FDA for KORSUVA
Injection for the treatment of CKD-aP in HD patients and the New Drug Application was evaluated by the FDA with Priority Review.
Important Safety Information
Warnings and Precautions
Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances:
These adverse reactions, including falls, have occurred in patients taking KORSUVA and may subside with continued treatment. Concomitant
use of centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the likelihood of these adverse
reactions and should be used with caution during treatment with KORSUVA.
Risk of Driving and Operating Machinery: Dizziness, somnolence, and
mental status changes have occurred in patients taking KORSUVA. KORSUVA may impair the mental or physical abilities needed to perform
potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery
until the effect of KORSUVA on their ability to do so is known.
The most common adverse reactions (incidence 2% and 1% higher
than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache
(4.5%), somnolence (4.2%), and mental status changes (3.3%).
Use in Specific Populations
Severe Hepatic Impairment: The influence of severe hepatic impairment
on the pharmacokinetics of KORSUVA in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA in this
population is not recommended.
Geriatric Use: The incidence of somnolence was higher in KORSUVA-treated
subjects aged 65 years and older (7.0%) than in KORSUVA-treated subjects less than 65 years of age (2.8%). The incidence was comparable
in both placebo age groups (3.0% and 2.1%, respectively).
KORSUVA is indicated for the treatment of moderate to severe pruritus
associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
Limitation of Use: KORSUVA has not been studied in patients on peritoneal
dialysis and is not recommended for use in this population.
Please see KORSUVA injection full Prescribing Information
About 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