AstraZeneca’s Lokelma approved in Japan for the treatment of hyperkalaemia

AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in Japan for the treatment of patients with hyperkalaemia (elevated levels of potassium in the blood).

The approval by Japan’s Ministry of Health, Labour and Welfare was based on positive results from stand-alone studies in Japan and global clinical trial programmes. It was also supported by DIALIZE, a global trial for end-stage renal disease patients on haemodialysis, which demonstrated the positive efficacy and safety of Lokelma in the management of hyperkalaemia.

Lokelma is the first innovative non-resin potassium binder to be approved in Japan. Traditional resin-based binders are often associated with poor tolerability.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “More than 300,000 patients in Japan suffer from hyperkalaemia, typically as result of chronic kidney disease or as a side effect from medications for heart failure. This approval ensures that this broad patient population, including those suffering from hyperkalaemia and patients with hyperkalaemia on stable haemodialysis, can benefit from Lokelma’s rapid, sustained potassium control and tolerability.”

The global clinical trial programme showed that for patients receiving Lokelma, for up to 12-months in duration, the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline. Lokelma demonstrated a rapid reduction of potassium in the blood as early as one hour with one dose and a sustained treatment effect for up to one year. In the DIALIZE trial, Lokelma demonstrated significantly improved control of pre-dialysis hyperkalaemia compared with placebo. Lokelma was well tolerated, with few serious adverse events. Results in Japanese patients were broadly consistent with those seen in the global programme.

Lokelma is approved for the treatment of hyperkalaemia in the US, EU, Canada, Hong Kong, China, Russia and Japan.

Hyperkalaemia

High levels of potassium in the blood (generally classified as >5mmol/l) characterise hyperkalaemia. The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system inhibitors, which can increase potassium in the blood. Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or HF with an estimated 700 million and 64 million people, respectively, living with each condition worldwide.

Lokelma

Lokelma (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally, is odourless, tasteless and stable at room temperature. The Lokelma global clinical trials programme consists of multiple trials of up to 12-months duration. The Japan clinical data package included 11 trials; four pivotal trials that Japanese patients participated in and seven supportive overseas trials. The efficacy and safety of Lokelma in Japanese patients were evaluated primarily in Japan stand-alone trials and international trials including Japanese patients.