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(Alliance News) - AstraZeneca PLC on Friday said its Lokelma drug was effective at treating hyperkalaemia in patients with end-stage rental disease who were on haemodialysis.
Hyperkalaemia is characterised by having elevated levels of potassium in the blood and the risk of hyperkalaemia is associated with chronic kidney disease, diabetes, and heart failure.
In the eight-week, 196-patient phase 3b Dialize trial of Lokelma 41% of patients taking the drug maintained normal potassium levels pre-dialysis on at least 3 in 4 dialysis treatments and did not need urgent rescue therapy, versus only 1% with placebo.
Lokelma's safety profile and tolerability in the Dialize trial "was consistent with previous trials" and the trial results was both statistically significant and clinically meaningful.
Elisabeth Bjork, senior vice president at Astra, said: "These positive results show that Lokelma can normalize potassium levels in between dialysis sessions for patients with hyperkalaemia who have end-stage renal disease. There is a high unmet treatment need that affects a large patient population and we believe Lokelma can play a critical role."
At present, Lokelma is approved and available in the US and EU to treat adults with hyperkalaemia. However, data from Dialize will be used to support updating the label for the drug in the EU and US because the dosing regimen used in the trial is not approved at present.
Shares in AstraZeneca were up 0.5% at 6,224.00 pence on Friday at midday.
