Marketing Authorisation Granted for Veltessa® (Patiromer) To Treat Patients With Hyperkalaemia

Marketing Authorisation Granted for Veltessa® (Patiromer) To Treat Hyperkalaemia

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA AND VIFOR PHARMA UK TODAY ANNOUNCED THAT THE EUROPEAN COMMISSION (EC) HAS GRANTED MARKETING AUTHORISATION OF VELTASSA® (PATIROMER) FOR THE TREATMENT OF ELEVATED SERUM POTASSIUM LEVELS (HYPERKALAEMIA) IN ADULTS

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).

The European licensing of patiromer, which applies to the UK, marks the first new drug developed specifically for the treatment of hyperkalaemia in nearly 60 years. Patiromer is a potassium binder that helps to enable optimal dosing of life-preserving therapies in heart failure and chronic kidney disease, and will be available for use in the UK later this year.

Hyperkalaemia presents a challenge for both cardiologists and nephrologists when managing existing RAAS inhibitor therapy which can lead to elevated potassium. Previously, treatment options that manage potassium overload have been limited to therapies first developed nearly 60 years ago. 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”.

In the UK, around 2.6 million people suffer with late stage CKD, around half of which have hyperkalaemia. There are also nearly one million HF patients, 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.

“For nearly 60 years there have been no new treatments specifically developed and indicated for persistent elevated potassium, available in Europe,” says Marco Windisch, General Manager, Vifor Fresenius Medical Care Renal Pharma UK Ltd. “The European Commission licencing of patiromer in hyperkalaemia will help many patients better manage elevated potassium and get the maximum benefit from their life preserving renin angiotensin aldosterone system inhibitor therapy.”

Patiromer has been indicated to treat hyperkalaemia, a potentially life-threatening condition in which there is an abnormally high concentration of potassium ions in the blood (with serum potassium levels >5 mmol/l or >5.5 mmol/l) which is associated with increased risk of mortality. HF and CKD patients are at highest risk of developing hyperkalaemia as a result of RAAS inhibitors.

However, RAAS inhibitor treatments inhibit renal potassium excretion, improve CKD patient outcomes and when combined with beta blockers to form ‘triple therapy’, can reduce mortality by 30% in HF patients.

  • 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.