AstraZeneca receives EU approval for hyperkalaemia drug Lokelma

AstraZeneca has announced that its hyperkalaemia therapy Lokelma has been approved by the European Commission.

This highly-selective oral potassium-removing agent is designed 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.

Data from three placebo-controlled trials and one open-label trial was submitted to support this approval, showing that patients with hyperkalaemia receiving Lokelma were able to rapidly achieve normal potassium levels in the blood and sustained potassium control for up to one year.

Elisabeth Bjork, vice-president and global head of cardiovascular, renal and metabolism medicines development at AstraZeneca, said: "Today's approval of Lokelma addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalaemia."

Lokelma is currently under separate regulatory review in the US, with a decision expected from the US Food and Drug Administration in the first half of 2018.

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