The European Commission has granted marketing authorisation for sodium-free potassium binder, patiromer (Valtessa; Vifor Fresenius Medical Care Renal Pharma, Vifor UK), for the treatment of hyperkalaemia in adults.
Robert Lewis, consultant nephrologist and chief of Service of the Wessex Kidney Centre in Portsmouth Hospital, Portsmouth, UK, adds, “The licensing of patiromer is an important advance for clinicians treating the estimated one million people living with chronic kidney disease (CKD) and hyperkalaemia. With this drug, nephrologists will be able to optimise the management of CKD using agents which are of proven value, but which have until now been limited by their tendency to elevate potassium levels”.
There are also nearly one million heart failure (HF) patients in the UK, of which 2-3% are thought to have hyperkalaemia. Current guidelines recommend treating HF and CKD patients with RAAS inhibitors, but despite their proven benefit, they can also lead to elevated potassium levels which can potentially lead to organ failure. Patiromer has been found to optimise treatment of cardiovascular and renal conditions by safely reducing potassium and addressing challenges clinicians face with current treatment regimens.
The EC licensing of patiromer is based on a clinical development programme that included the following studies:
- Pivotal Phase III OPAL-HK study, which evaluated patiromer treatment in patients with hyperkalaemia and CKD who were taking RAAS inhibitors.
- Phase II AMETHYST-DN trial, which evaluated the use of patiromer over 52 weeks in patients with hyperkalaemia, CKD and type 2 diabetes who were taking RAAS inhibitors.
- An open-label, Phase I study that evaluated the onset-of-action of patiromer in CKD patients with hyperkalaemia