FDA Approves Lokelma for Hyperkalemia Treatment
Lokelma is approved for the treatment of hyperkalemia, which is characterized by elevated potassium levels often associated with cardiovascular, renal, and metabolic diseases.
Today the US Food and Drug Administration announced its approval of sodium zirconium cyclosilicate (Lokelma) for the treatment of hyperkalemia in adults.
A serious condition, hyperkalemia is characterized by elevated potassium levels often associated with cardiovascular, renal, and metabolic diseases. Lokelma, manufactured by AstraZeneca, is a highly-selective oral potassium-removing agent.
In March 2018, the European Commission (EC) granted AstraZeneca permission to market Lokelma in the European Union.
This approval would help address the life-threatening condition, said Elisabeth Björk, MD, PhD, vice president, head of cardiovascular, renal and metabolism, global medicines development at AstraZeneca.
“The consequences of hyperkalemia can be serious, even life-threatening, and can occur in patients either with chronic kidney disease or as a result of taking some medications for heart failure,” said Björk in a statement following the EC approval. “Today’s approval of Lokelma addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalemia.”
This approval drew on data from a 2-part, double-blind, randomized, placebo-controlled clinical trial (NCT01737697) in patients with hyperkalemia. The first phase included 753 patients with various conditions leading to hyperkalemia, including chronic kidney disease 60%, heart failure 10%, and diabetes mellitus 62%. Additionally, 67% were on renin angiotensin aldosterone system (RAAS) inhibitor therapy at baseline.
The study met its primary endpoint of a greater reduction in serum potassium levels for the 2.5g (-0.5; 95% CI; -0.5, -0.4), 5g (-0.5; 95% CI; -0.6, -0.5) and 10 g (-0.7; 95% CI; -0.8, -0.7) (3 times a day) dose groups compared to the placebo group (-0.2; 95% CI; -0.3, -0.2) P <0.001). during the initial 48 hours of study drug treatment.
In a subsequent 12-month, open-label trial, 99% of 751 hyperkalemic patients taking 10g of Lokelma 3 times a day achieved normokalemia (3.5-5.0 mEq/L) within 72 hours.
The initial recommended dose of Lokelma is 10 g administered 3 times a day for up to 48 hours. The recommended dose for ongoing treatment is 10 g once daily.
In placebo-controlled trials of the drug, edema was reported as an adverse event. In patients who were treated with Lokelma once per day edema was reported in 4.4% of patients receiving 5 g, 5.9% of patients receiving 10 g, and 16.1% of patients receiving 15 g, compared to 2.4% of patients receiving placebo.
