FDA approves new indication for Lokelma
The FDA has updated the dosing regimen for Lokelma to allow treatment of hyperkalemia in patients with end-stage kidney disease who are on chronic hemodialysis.
Lokelma (sodium zirconium cyclosilicate) is a potassium binder made by AstraZeneca indicated for the treatment of hyperkalemia in adult patients. Previously, dosing was not established for patients with ESKD on chronic hemodialysis.
“More than 500,000 patients in the U.S. are living with dialysis-dependent end-stage renal disease and could be at risk for dangerously high levels of potassium,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in a press release. “With this FDA approved update, the Lokelma label now includes important dosing guidance for treating hyperkalemia in patients on hemodialysis.”
The company said that approval was based on results from the double-blind, placebo-controlled phase 3b Dialize trial that evaluated the efficacy of Lokelma in 196 chronic hemodialysis patients with persistent pre-dialysis hyperkalemia (mean baseline potassium 5.8 mEq/L).
Results showed the Lokelma treatment arm had a significantly greater proportion of responders compared with placebo (41.2% vs. 1%), the company said. Additionally, 2.1% of patients treated with Lokelma needed rescue therapy to reduce serum potassium for severe hyperkalemia during the treatment period compared with 5.1% of the placebo arm.
The safety profile of Lokelma was consistent with that seen in previous trials.
The company said the label update for Lokelma is the first in the United States following its FDA approval in 2018 to treat adults with hyperkalemia. With the FDA approval, the label update for patients on chronic hemodialysis now includes a starting dose of 5 g once daily on non-dialysis days and a starting dose of 10 g once daily on nondialysis days in patients with serum potassium greater than 6.5 mmol/L.
Lokelma is approved in the United States, European Union, Canada, Hong Kong, China, Russia and Japan, the company said.