AZ to file potential blockbuster potassium drug in Asia

AstraZeneca is planning filings of its high potassium drug Lokelma in Asia, following supportive trial findings.

The company made the announcement as it presented findings of the phase III HARMONIZE Global trial, which tested the drug in patients with high potassium levels, or hyperkalemia, in Japan, Korea, Taiwan, and Russia.

HARMONIZE is a randomised, multicentre, double-blinded, placebo-controlled trial involving 267 patients with hyperkalemia in 47 study locations across the Asia Pacific region.

Patients who achieved normokalemia – normal potassium rates – during the first 48 hours with Lokelma 10g three times daily, progressed to the 28-day maintenance phase of the trial.

Patients in the maintenance phase were randomised to receive Lokelma 5g or 10g, or placebo, administered once daily.

Results show normokalemia was maintained with statistically-significant differences observed, irrespective of dose, for Lokelma versus placebo in terms of mean potassium levels during days 8-29 of the maintenance phase.

The safety profile of Lokelma observed in HARMONIZE Global was consistent with previous trials.

Lokelma could be a blockbuster drug for AstraZeneca, after getting approval in the US and EU this year after delays caused by issues with a manufacturing plant in Texas.

European regulators approved the drug formerly known as ZS-9 in March after their concerns over the issues were resolved, and after two previous rejections the US regulator approved it in May after saying it was satisfied with the technical arrangements at the facility.

AZ gained rights to the drug after buying ZS Pharma in 2015 for $2.7 billion.

Lokelma (sodium zirconium cyclosilicate) will compete with Vifor Pharma group member Relypsa’s rival Veltassa (patiromer), which has been on the market for a few years in the US and Europe.

The Anglo-Swedish pharma has predicted sales in excess of $1 billion annually for ZS-9, although some analysts say this is a conservative estimate.

Elisabeth Björk, head of cardiovascular, renal and metabolism, global medicines development, AstraZeneca, said: “The positive results of HARMONIZE Global add to the growing body of evidence supporting the use of Lokelma for adults with hyperkalemia, a serious condition associated with chronic kidney disease, heart failure and diabetes as well as the use of renin-angiotensin-aldosterone system inhibitors.

“Through our robust clinical programme we are committed to assessing the potential of Lokelma in the broadest range of patient populations possible, including markets with high unmet medical need.”