New drug for hyperkalaemia given EC approval
The European Commission has approved patiromer (Veltassa®) for the treatment of hyperkalaemia, which marks the first new drug licenced specifically for the treatment of hyperkalaemia in over 60 years.
Patiromer is a sodium-free potassium binder licensed for the treatment of hyperkalaemia in adult patients. Hyperkalaemia is a potentially life-threatening condition which can cause fatal cardiac arrest and muscle paralysis. This therapy can also be made available to patients who develop hyperkalaemia while being treated with Renin-Angiotensin-Aldosterone-System (RAAS) inhibitor therapy – typically used in heart failure (HF) and chronic kidney disease (CKD).
Dr Robert Lewis, Consultant Nephrologist and Chief of Service of the Wessex Kidney Centre in Portsmouth Hospital adds, “The licensing of patiromer is an important advance for clinicians treating the estimated one million people living with chronic kidney disease and hyperkalaemia. With this drug, nephrologists will be able to optimise the management CKD using agents which are of proven value, but which have until now been limited by their tendency to elevate potassium levels”.
The EC licensing of patiromer is based on a comprehensive 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.
Patiromer data from the European Medicines Agency