Hyperkalaemia treatment approved for marketing in EU

Veltassa, a sodium-free potassium binder treatment for hyperkalaemia, has been approved for marketing by the European Commission (EC) with the first launches planned for the end of this year or early next year.

The therapy, which is approved for treatment of adult patients, can also be made available to patients who develop hyperkalaemia while being treated with renin angiotensin aldosterone system (RAAS) inhibitor therapy.

“We are delighted to be able to offer Veltassa to hyperkalaemia patients, including those on RAASi therapy, in the EU and in Norway, Liechtenstein and Iceland. With Veltassa, patients have an option that is easy to take, keeps potassium levels stable and makes their hyperkalaemia so much easier to manage. In particular, Veltassa makes it possible for patients to continue with their optimal RAASi dose in order to get the maximum benefit from their life-saving RAASi treatment,” said Stefan Schulze, president of the Executive Committee and COO of Vifor Pharma. “With Veltassa we are able to offer an effective medicine that is in line with our aim to deliver innovative, patient-focused solutions. This approval is also another milestone towards our vision of global leadership in cardio-renal therapies.”

Veltassa was developed by Relypsa, a Vifor Pharma Group company, which is a biopharmaceutical company focused on the discovery, development and commercialisation of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract.

The therapy was approved by the US Food and Drug Administration (FDA) for the treatment of hyperkalaemia in the US in October 2015, with availability to patients since December of the same year. Marketing authorisation applications for Veltassa have been submitted and are under review in Switzerland and Australia, and are planned in other markets worldwide.