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SWISSMEDIC HAS APPROVED PATIROMER TO BE MARKETED IN SWITZERLAND AS VELTASSA® FOR THE TREATMENT OF HYPERKALAEMIA (ELEVATED SERUM POTASSIUM LEVELS) IN ADULTS.
Veltassa® is a sodium-free potassium binder approved for the treatment of hyperkalaemia in adults. This therapy can also be made available to patients who develop hyperkalaemia while being treated with drugs inhibiting the renin-angiotensin-aldosterone system, including e.g. angiotensin-converting enzyme inhibitors, angiotensin receptor blockers (sartans) and aldosterone antagonists, which are often used to treat hypertension or heart failure. Nearly all patients treated with Veltassa® in the phase II-III clinical programme were on renin angiotensin aldosterone system inhibitors (RAASi) at baseline. Veltassa® is expected to be available for patients during the first half year of 2018.
"With Veltassa®, patients in Switzerland have a therapy option for long-term control of potassium that is easy to take. Veltassa® makes it possible for them to continue with their optimal dose of RAASi in order to get the maximum benefits of their treatment, said Stefan Schulze, Vifor Pharma Group President of the Executive Committee and COO. "With Veltassa® we are able to offer an effective medicine that is in line with our aim to deliver innovative, patient-focused solutions."
Developed by Relypsa, Veltassa® was approved by the US Food and Drug Administration (FDA) for the treatment of hyperkalaemia in the US in October 2015 and has been available to patients in the US since December 2015. Veltassa® was approved in the EU, Norway, Iceland and Liechtenstein in July 2017, and in Australia in December 2017. Other applications are planned in other markets worldwide.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty 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 headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.
Vifor Pharma, a company of the Vifor Pharma 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 and non-prescription medicines. Vifor Pharma's operational headquarters are in Zurich, Switzerland, and the company has an increasingly global presence and a broad network of affiliates and partners around the world.
Hyperkalaemia, or abnormally elevated levels of potassium in the blood, is a serious condition that can lead to life-threatening cardiac arrhythmia and sudden death. It is frequently prevalent in patients who suffer from chronic kidney disease (CKD), hypertension, diabetes and/or heart failure. Patients with CKD or heart failure are at particular risk for developing hyperkalaemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors, which can increase blood potassium levels in patients taking these medicines. 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 hyperkalaemia as a side effect. These include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.
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.