Vifor Pharma AG (VTX: VIFN) has received approval from Swissmedic for patiromer to be marketed as Veltassa in Switzerland for the treatment of hyperkalaemia (elevated serum potassium levels) in adults, the company disclosed on Thursday.
Hyperkalaemia is a serious condition that can lead to life-threatening cardiac arrhythmia and sudden death. It is prevalent in patients suffering from chronic kidney disease (CKD), hypertension, diabetes and/or heart failure.
Veltassa is a sodium-free potassium binder that has been approved as a treatment for hyperkalaemia in adults. It can also be an available therapy for patients who develop hyperkalaemia while receiving treatment inhibiting the renin-angiotensin-aldosterone system, which is often used to treat hypertension or heart failure. This includes angiotensin-converting enzyme inhibitors, angiotensin receptor blockers (sartans) and aldosterone antagonists.
In the Phase II-III clinical programme, nearly all the patients receiving Veltassa were on renin-angiotensin-aldosterone system inhibitors (RAASi) at baseline.
Veltassa, which was developed by Relypsa, was approved by the US Food and Drug Administration (FDA) for hyperkalaemia in October 2015 and has been available to patients since December 2015. It was approved in the EU, Norway, Iceland and Liechtenstein in July 2017 and in Australia in December 2017. In Switzerland, it is expected that Veltassa will be available during the first half of 2018.
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