The Committee for Medicinal Products for Human Use (CHMP) of The European Medicines Agency (EMA) has recommended marketing authorization for Veltassa (patiromer) in all 31 EU/EEA countries to treat hyperkalaemia in adults.
Almost all patients treated with Veltassa in the phase II-III clinical program were on renin angiotensin aldosterone system inhibitor therapy (RAASi) at baseline.
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The CHMP’s recommendation to approve Veltassa is based on the following studies:
- Pivotal Phase III OPAL-HK study, which evaluated Veltassa treatment in hyperkalaemic patients with CKD who were taking renin angiotensin aldosterone system (RAAS) inhibitors.
- Phase II AMETHYST-DN trial, which evaluated the use of Veltassa over 52 weeks in hyperkalaemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors.
- An open-label, uncontrolled, Phase I study that evaluated the onset-of-action of Veltassa® in hyperkalaemic CKD patients.
The U.S. Food and Drug Administration approved Veltassa, developed by Relypsa, to treat hyperkalaemia in October 2015. Marketing applications for Veltassa have been submitted and are under review in Switzerland and Australia and are planned in other markets worldwide. Vifor Pharma Group acquired Relypsa in July 2016.