AstraZeneca's Lokelma (Sodium Zirconium Cyclosilicate) Approved in Japan and China, Marking a New Era in Hyperkalemia Treatment

March 27, 2020/Bio ValleyBIOON/--AstraZeneca(AstraZeneca) recently announced that its novel oral potassium-lowering drug, Lokelma (brand name in China: Libezhuo; generic name: sodium zirconium cyclosilicate), has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of hyperkalemia in adults. Notably, Lokelma is the first novel non-resin potassium binder approved in Japan, whereas traditional resin-based potassium binders are often associated with poor tolerability.

This approval is based on positive results from an independent study conducted in Japan and a global clinical trial program. The approval was also supported by globalClinical TrialsSupported by data from the DIALIZE study, which was conducted in patients with end-stage renal disease (ESRD) on stable dialysis therapy and hyperkalemia, the results confirmed the favorable efficacy and safety of Lokelma in treating hyperkalemia in this patient population.

From around the worldClinical TrialData from the program show that Lokelma begins to take effect within 1 hour of administration, with a median time of 2.2 hours to achieve normal serum potassium levels, and 98% of patients reaching normal serum potassium levels within 48 hours. Nearly 90% of patients maintained normal serum potassium levels over one year of treatment, with safety comparable to placebo and good tolerability over one year of treatment. In the DIALIZE trial, Lokelma significantly improved control of pre-dialysis hyperkalemia compared with placebo. Results in Japanese patients were generally consistent with those from the global program.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “In Japan, more than 300,000 patients suffer from hyperkalemia, typically as a side effect of chronic kidney disease or medications for heart failure. This approval ensures that a broad patient population can benefit from Lokelma’s rapid and sustained potassium control and tolerability, including patients with hyperkalemia and those with hyperkalemia undergoing stable hemodialysis.”

Hyperkalemia (typically defined as a serum potassium level >5.0 mmol/L) is a serious condition characterized by elevated potassium levels in the blood. It is highly prevalent among patients with chronic kidney disease (CKD) and/or heart failure (HF), with an even higher risk observed in patients undergoing hemodialysis or those receiving conventional cardiac medications, such as renin-angiotensin-aldosterone system (RAAS) inhibitors. Globally, there are up to 700 million patients with CKD and up to 64 million patients with HF. Among patients with CKD and/or HF, the incidence of hyperkalemia ranges from 23% to 47%.

The active pharmaceutical ingredient of Lokelma is sodium zirconium cyclosilicate, a water-insoluble, non-absorbed potassium binder indicated for the treatment of hyperkalemia in adults. Sodium zirconium cyclosilicate utilizes an innovative ion-trapping technology with high selectivity for potassium ions, resulting in a faster onset of action and better tolerability. Regardless of the underlying cause of hyperkalemia, and irrespective of age, sex, race, presence of comorbidities, or concomitant use of RAAS inhibitors, sodium zirconium cyclosilicate can reduce serum potassium levels in patients and maintain them within the normal range. In patients with hyperkalemia worldwideClinical TrialsIts efficacy and safety have been extensively demonstrated in pharmacodynamic studies conducted in China.

To date, Lokelma has been approved in the United States, the European Union, Canada, Russia, China, and Japan. In China, Lokelma (Lokelma) was approved in January this year for the treatment of hyperkalemia in adults. The field of pharmacological management for hyperkalemia experienced a nearly 60-year gap. As the first innovative drug launched in China for this indication, the approval of sodium zirconium cyclosilicate powder marks the dawn of a new era in the treatment of hyperkalemia in China. (Bioon.com)

Original source: Lokelmaapproved in Japan for the treatment of hyperkalaemia