The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation in all 31 EU/EEA countries for patiromer (brand name Veltassa®) for the control of elevated serum potassium levels (hyperkalaemia) in adult patients.
The recommendation includes patients who develop hyperkalaemia while being treated with renin angiotensin aldosterone system (RAAS) inhibitor therapy.
The availability of patiromer in the United Kingdom is currently scheduled for the second half of 2017 following the EU commission’s decision.
There are approximately 900,000 people in the UK with chronic heart failure (CHF) and around three million people in England with chronic kidney disease (CKD). Nearly half of these CKD patients may have hyperkalaemia.
Hyperkalaemia occurs when potassium levels are equal to or exceed 5.5 mmol/L in the blood.
Although RAAS inhibitors have proven benefits in CKD and CHF patients, they can increase the risk of hyperkalaemia.
The potential of patiromer to enable simultaneous RAAS inhibitor therapy was demonstrated in the patiromer phase II-III clinical programme, in which nearly 100% of patients were on RAAS inhibitor therapy at baseline.
Janine Hogan, Communication Manager at Vifor Pharma, said: “For over 50 years there have been no new treatments for persistent elevated potassium available in Europe.
“This encouraging recommendation for the use of patiromer in hyperkalaemia brings us one step closer towards helping patients achieve better health outcomes by optimising current treatment regimens.”