AstraZeneca has announced, in a March 26, 2020 press release, that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).
Lokelma is a non-resin potassium binder and its approval by Japan’s Ministry of Health, Labor, and Welfare, represents the first of its kind for the country. The approval was based on the positive results from standalone studies performed in Japan and global clinical trial programs. Additionally, the decision to approve Lokelma was supported by DIALIZE—a global trial for end-stage renal disease patients on hemodialysis.
“More than 300,000 patients in Japan suffer from hyperkalemia, typically as result of chronic kidney disease or as a side effect from medications for heart failure,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, in the press release. “This approval ensures that this broad patient population, including those suffering from hyperkalemia and patients with hyperkalemia on stable hemodialysis, can benefit from Lokelma’s rapid, sustained potassium control and tolerability.”