Patiromer for Hyperkalemia Recommended for Marketing in EU

May 19, 2017

LONDON, UK — The potassium-binding agent patiromer (Veltassa, Relypsa) has gained a positive marketing recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for the indication of managing hyperkalemia[1]. The decision will now be considered by the European Commission for possible adoption throughout the EU.

In February, the CHMP handed down a similar recommendation for another potassium binder, sodium zirconium cyclosilicate (ZS-9, AstraZeneca).

Patiromer was approved by the US Food and Drug Administration in 2015 primarily on the results of the phase 2 AMETHYST-DN study. In that trial, daily patiromer administration for a year was seen to safely control mild to moderate hyperkalemia secondary to treatment with renin-angiotensin-aldosterone-system (RAAS)–inhibiting agents in patients with diabetic nephropathy, with or without heart failure.

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