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. 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.
Cite this: Patiromer for Hyperkalemia Recommended for Marketing in EU - Medscape - May 19, 2017.