FDA approves Lokelma to treat hyperkalaemia.-AstraZeneca.

The FDA has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia, a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood. To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death.

Lokelma is a highly-selective, oral potassium-removing agent. The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label trials, which showed that for patients receiving Lokelma the onset of action was at 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours from baseline. The treatment effect was maintained for up to 12 months.

Comment: ZS 9 differs from existing drugs on the market, namely generic kayexalate and Veltassa which are organic polymers. ZS 9 is a proprietary zirconium silicate and is administered orally. Veltassa carries a black box warning about binding to other medicines and also has a slower onset of action. There is a definite unmet medical need in the high potassium market. Older drugs such as sulfonate potassium binding resins have safety risks, such as intestinal necrosis.