26th Mar 2020 08:55
(Alliance News) - AstraZeneca PLC on Thursday said its drug Lokelma has now been approved in Japan to treat hyperkalaemia, which is characterised by high levels of potassium in the blood.
Shares in FTSE 100-listed drug maker Astra were down 3.7% at 6,660.00 pence in London in morning trading.
The Japanese Ministry of Health, Labour & Welfare approved Lokelma, which contains sodium zirconium cyclosilicate, for hyperkalaemia on the basis of positive results in stand-alone studies as well as Astra's global clinical trial programmes.
The global trial programme showed that patients receiving Lokelma for up to 12 months achieved normal potassium blood levels at a median time of 2.2 hours, with 98% of patients reaching normal levels within 48 hours.
The approval was also supported by Dialize's global trial of Lokelma in end-stage renal disease patients on dialysis. This trial showed that Lokelma "demonstrated significantly improved control of pre-dialysis hyperkalaemia compared with placebo" and "was well tolerated, with few serious adverse events".
Hyperkalaemia is a much higher risk in chronic kidney disease patients, as well as those taking common heart failure medications. Between 23% and 47% of patients with chronic kidney disease or heart failure develop hyperkalaemia.
Lokelma is the first non-resin potassium binder approved in Japan, with resin-based binders "often associated with poor tolerability".
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at Astra, 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."
By Anna Farley; [email protected]
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