FDA approves Lokelma approved for the treatment of adults with hyperkalemia

Following a complete response letter issued by the agency in March 2017, the US Food and Drug Administration on Friday approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalemia, a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.

The drug’s developer, AstraZeneca (LSE: AZN), gained Lokelma approval in the European Union in March for the treatment of adults with hyperkalemia,

The risk of hyperkalemia 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 hyperkalemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death.