ZURICH–(BUSINESS WIRE)–Regulatory News:
Vifor Pharma today announced that treatment of the first patient in
their global phase-IIIb DIAMOND study has begun. The study will evaluate
the potential of Veltassa® to improve outcomes by enabling
heart failure (HF) patients, with or without chronic kidney disease
(CKD), to be treated with renin-angiotensin-aldosterone system
inhibitors (RAASi) therapy in accordance with HF treatment guidelines1,2.
Presently, RAASi treatment is frequently discontinued due to the risk of
hyperkalaemia (elevated blood potassium levels).
The DIAMOND study is designed to further support the use of Veltassa®
to effectively control high blood potassium levels, thereby enabling
optimal RAASi therapy in HF patients. It is a global, multicentre,
double-blind, placebo-controlled trial aiming to study approximately
2,400 patients in over 400 sites. Eligible patients will have HF (with
or without CKD) with either current hyperkalaemia at screening or a
history of hyperkalaemia in the past year that led to a reduction or
discontinuation of RAASi therapy. The primary endpoint of the study is
the time to first occurrence of cardiovascular death or cardiovascular
hospitalisation. Top-line results are expected in 2022.
Hyperkalaemia can cause life-threatening abnormal heart rhythms and even
sudden death3. There are often no warning signs, meaning a
person can unknowingly experience recurring spikes in potassium levels
and be at risk of cardiac events. The risk of hyperkalaemia can be a
barrier to initiating and maintaining HF and CKD patients on
guideline-recommended therapies such as RAASi treatment1,2.
RAASi therapy has been shown to improve cardiovascular and renal
outcomes and is proven to prolong survival and reduce hospitalisation.
Its use is strongly recommended in clinical guidelines for the treatment
of HF with reduced ejection fraction, and CKD1,2. Across the
Veltassa® clinical trial program, over 99 percent of
participants were also taking RAASi therapy. However, these therapies
can increase blood potassium levels, which can lead to hyperkalaemia.
“Guidelines give their strongest recommendation to use RAASi therapy to
improve mortality and morbidity in patients with heart failure and with
kidney disease, but unfortunately they are often discontinued because
they can cause hyperkalaemia,” said Professor Javed Butler, primary
investigator of the DIAMOND study and chairman of the Department of
Medicine, University of Mississippi Medical Center, US. “DIAMOND is a
very important study that will help the medical community better
understand the value of Veltassa® in treating hyperkalaemia
and enabling patients to stay on these life-saving medicines.”
Additional details on the study are available on www.clinicaltrials.gov.
Approximately 73 percent of advanced CKD
and 40 percent of chronic HF patients may be at risk of elevated blood
potassium levels4. Hyperkalaemia can cause abnormal heart
rhythms and even sudden death3. 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 and reduce
mortality can cause hyperkalaemia as a side effect. These may include
RAASi such as angiotensin receptor blockers (ARBs), aldosterone
antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors as
well as angiotensin II receptor/neprilysin inhibitors (ARNI).
Veltassa® is a
sodium-free potassium binder approved for the treatment of
hyperkalaemia. Veltassa® should not replace emergency
treatment for life-threatening hyperkalaemia. Made in powder form
consisting of smooth, spherical beads, Veltassa® is mixed
with water 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 about Veltassa® in the
Veltassa® 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.
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
The most common adverse reactions
(incidence ≥2 percent) are 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 Veltassa®’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.
Vifor Pharma Group is a global pharmaceuticals company
headquartered in Switzerland. It aims to become the global leader in
iron deficiency, nephrology and cardio-renal therapies. The company is
the 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; Vifor Fresenius Medical Care Renal Pharma (a
joint company with Fresenius Medical Care); Relypsa; and OM Pharma.
Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss
Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.
Relypsa, Inc., a Vifor Pharma Group company, is a
biopharmaceutical company focused on the development and
commercialisation of late-stage medicines in the iron deficiency,
nephrology and cardio-renal therapeutic areas. Relypsa is committed to
delivering innovative therapies and improving the lives of patients with
serious and life-threatening conditions that are often overlooked and
undertreated. The company’s first medicine, Veltassa®
(patiromer) for oral suspension, was approved by the U.S. FDA in October
2015, making it the first approved medicine for the treatment of
hyperkalaemia in more than 50 years. More information is available at www.relypsa.com.
1 Yancy C et al. American Heart Association. Guideline for
the Management of Heart Failure. August 2017. Accessible via http://www.ksw-gtg.com/hfguidelines/pdfs/HFTreatmentHypertensionHFrEF.pdf.
2 Ponikowski P et al. 2016 ESC Guidelines for the diagnosis
and treatment of acute and chronic heart failure: The Task Force for the
diagnosis and treatment of acute and chronic heart failure of the
European Society of Cardiology (ESC) European Heart Journal, Volume 37,
Issue 27, 14 July 2016, Pages 2129–2200.
3 Rastegar A, Soleimani M. Hypokalaemia and hyperkalaemia.
Postgrad Med J. 2001;77:759-764.
4 Rosano GCM, et al. Expert consensus document on the
management of hyperkalaemia in patients with cardiovascular disease
treated with renin angiotensin aldosterone system inhibitors:
coordinated by the Working Group on Cardiovascular Pharmacotherapy of
the European Society of Cardiology. Eur Heart J 2018;4:180-188.
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