Relypsa Announces Data on the Treatment and Impact of Hyperkalemia to be Presented at ASN Kidney Week 2016
November 03 2016 - 4:30PM
Relypsa, Inc., a Vifor Pharma Company, today announced five
posters, including new analyses from studies of Veltassa®
(patiromer) for oral suspension and new data on the impact of
hyperkalemia, will be presented at the American Society of
Nephrology's (ASN) Kidney Week 2016, taking place November 15-20,
2016 in Chicago, Illinois.
The Veltassa data being presented include:
- A new post-hoc analysis from the pivotal Phase 3 OPAL-HK study
that examined the effects of Veltassa on potassium, aldosterone,
plasma renin activity and blood pressure levels in patients with
hyperkalemia (elevated blood potassium levels) and chronic kidney
disease (CKD) who were stratified based on levels of aldosterone
and plasma renin activity at baseline. All patients were taking
renin angiotensin aldosterone system (RAAS) inhibitors.
- Results from a pooled post-hoc analysis of Phase 2 and 3
Veltassa trials evaluating whether there was evidence of adverse
pharmacodynamic interactions after initiation of Veltassa in
patients receiving blood pressure (antihypertensive)
medicines.
Three additional posters highlight the impact of
hyperkalemia:
- A meta-analysis of approximately 419,000 people evaluating the
relationship between blood potassium levels, death rates and
end-stage renal disease.
- An analysis evaluating the association between blood potassium
levels, hospitalization, death and emergency room visits in
hemodialysis patients and how these outcomes were impacted by the
day of the week.
- An analysis showing the cost of healthcare rises exponentially
as CKD progresses to later stages.
The ASN 2016 abstracts are available at www.asn-online.org.
Details for the poster presentations during ASN Kidney Week 2016
are listed below.
Veltassa Posters
Abstract Title: |
Aldosterone, renin and
blood pressure during patiromer treatment of hyperkalemia in
CKD |
Presenter: |
Matthew R. Weir, M.D.,
professor and director, Division of Nephrology, University of
Maryland School of Medicine |
Session: |
Fluid, Electrolyte,
Acid-Base Disorders |
Number: |
TH-PO479 |
Date and Time: |
Thursday, November 17,
10:00 a.m. – 12:00 p.m. CST |
Abstract Title: |
Evaluation of potential
pharmacodynamic interactions with antihypertensive drugs given
concomitantly with patiromer: Pooled analysis of Phase 2/3 clinical
trials |
Presenter: |
Matthew R. Weir, M.D.,
professor and director, Division of Nephrology, University of
Maryland School of Medicine |
Session: |
Fluid, Electrolyte,
Acid-Base Disorders |
Number: |
TH-PO480 |
Date and Time: |
Thursday, November 17,
10:00 a.m. – 12:00 p.m. CST |
|
|
Hyperkalemia and Chronic Kidney Disease
Posters
Abstract Title: |
Serum potassium and the
risk of adverse outcomes: A CKD Prognosis Consortium
meta-analysis |
Presenter: |
Csaba P. Kovesdy, M.D.,
Fred Hatch Professor of Medicine, director, Clinical Outcomes and
Clinical Trials Program, Division of Nephrology, University of
Tennessee Health Science Center |
Session: |
Fluid, Electrolyte,
Acid-Base Disorders |
Number: |
TH-PO475 |
Date and Time: |
Thursday, November 17,
10:00 a.m. – 12:00 p.m. CST |
Abstract Title: |
Serum potassium and
clinical outcomes among hemodialysis patients: Impact of the long
interdialytic interval |
Presenter: |
Steven Brunelli, M.D.,
vice president and medical director, Health Economics and Outcomes
Research, DaVita Clinical Research |
Session: |
Dialysis:
Noncardiovascular Outcomes–II |
Number: |
FR-PO974 |
Date and Time: |
Friday, November 18, 10:00
a.m. – 12:00 p.m. CST |
Abstract Title: |
Healthcare cost rises
exponentially by stage of chronic kidney disease |
Presenter: |
Ladan Golestaneh, M.D.,
M.S., associate professor of clinical medicine, Montefiore Medical
Center, Albert Einstein College of Medicine |
Session: |
CKD: Health Services,
Disparities, Prevention |
Number: |
SA-PO911 |
Date and Time: |
Saturday, November 19,
10:00 a.m. – 12:00 p.m. CST |
|
|
Exhibitor Spotlight
Title: |
Dietary and pharmacologic
management of electrolyte disorders in chronic kidney disease |
Presenter: |
Anjay Rastogi, M.D.,
Ph.D., associate clinical professor of medicine, University of
California Los Angeles Division of Nephrology |
Location: |
Exhibit Hall Theatre
#1 |
Date and Time: |
Friday, November 18, 12:00
p.m. – 1:00 p.m. CST |
|
|
About HyperkalemiaApproximately 3 million
people in the United States with stage 3 or 4 CKD and/or heart
failure have hyperkalemia, or elevated blood potassium levels.
Hyperkalemia can cause abnormal heart rhythms and even sudden
death. There are often no warning signs, meaning a person can
unknowingly experience spikes in potassium levels recurrently and
be at risk for these cardiac events. Some medicines that are often
prescribed to people with CKD and heart failure to help delay
progression of their underlying disease can cause hyperkalemia as a
side effect. These include RAAS inhibitors such as angiotensin
receptor blockers (ARBs), aldosterone antagonists (AAs) and
angiotensin-converting-enzyme (ACE) inhibitors.
About VeltassaVeltassa is a potassium binder
approved for the treatment of hyperkalemia. Veltassa should not be
used as an emergency treatment for life-threatening hyperkalemia
because of its delayed onset of action.
Made in powder form consisting of smooth, spherical beads,
Veltassa is mixed with water (one-third of a cup) and taken
once-a-day with food. Veltassa is not absorbed and acts within the
gastrointestinal tract. It binds to potassium in exchange for
calcium, primarily in the colon. The potassium is then excreted
from the body through the normal excretion process.
IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a
Boxed Warning that Veltassa binds to many other orally
administered medications, which could decrease their absorption and
reduce their effectiveness. Other oral medications should
be administered at least 6 hours before or 6 hours after Veltassa.
Doctors should choose Veltassa or the other oral medication if
adequate dosing separation is not possible.
ContraindicationsVeltassa is contraindicated in
patients with a history of a hypersensitivity reaction to Veltassa
or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with
severe constipation, bowel obstruction or impaction, including
abnormal post-operative bowel motility disorders, because Veltassa
may be ineffective and may worsen gastrointestinal conditions.
Patients with a history of bowel obstruction or major
gastrointestinal surgery, severe gastrointestinal disorders, or
swallowing disorders were not included in clinical studies.
Hypomagnesemia Veltassa binds to magnesium in
the colon, which can lead to hypomagnesemia. In clinical studies,
hypomagnesemia was reported as an adverse reaction in 5.3 percent
of patients treated with Veltassa. Approximately 9 percent of
patients in clinical trials developed hypomagnesemia with a serum
magnesium value <1.4 mg/dL. Doctors should monitor serum
magnesium and consider magnesium supplementation in patients who
develop low serum magnesium levels.
Adverse Reactions The most
common adverse reactions (incidence ≥2 percent) were constipation,
hypomagnesemia, diarrhea, nausea, abdominal discomfort and
flatulence. Mild to moderate hypersensitivity reactions were
reported in 0.3 percent of patients treated with Veltassa and
included edema of the lips.
For additional Important Safety Information and Veltassa’s full
Prescribing Information, please visit
www.relypsa.com/veltassa/prescribing-information.
About Relypsa, Inc.Relypsa, Inc. is a
biopharmaceutical company focused on the discovery, development and
commercialization of polymeric medicines for patients with
conditions that are often overlooked and undertreated and can be
addressed in the gastrointestinal tract. The Company's first
medicine, Veltassa® (patiromer) for oral suspension, was developed
based on Relypsa's rich legacy in polymer science. Relypsa was
founded in 2007 and, in September 2016, became a Vifor Pharma
company. More information is available at
www.relypsa.com.
About Vifor PharmaVifor Pharma,
a company of the Galenica Group, is a world leader in the
discovery, development, manufacturing and marketing of
pharmaceutical products for the treatment of iron deficiency. The
company also offers a diversified portfolio of prescription
medicines as well as over-the-counter (OTC) products. Vifor Pharma,
headquartered in Zurich, Switzerland, has an increasingly global
presence and a broad network of affiliates and partners around the
world. For more information about Vifor Pharma, please visit
www.viforpharma.com.
Contact:
Charlotte Arnold
Vice President, Corporate Communications and Investor Relations
650.421.9352
media@relypsa.com
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