AstraZeneca gets European OK for drug that cuts potassium levels

257
AstraZeneca photo
Advertisement
 
 AstraZeneca announced that the European Commission has granted marketing authorization for Lokelma for the treatment of adults with hyperkalaemia.

Hyperkalaemia is a condition characterized by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.

The approval is supported by data from three double-blind, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months. In these trials, for patients receiving Lokelma 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 also demonstrated sustained potassium control for up to one year.4,5

The risk of hyperkalaemia increases significantly for patients with chronic kidney disease and for those who take common life-saving medications for heart failure.

Elisabeth Björk, vice president, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, AstraZeneca, said: “The consequences of hyperkalaemia can be serious, even life-threatening, and can occur in patients either with chronic kidney disease or as a result of taking some medications for heart failure. Today’s approval of Lokelma addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalaemia.”

Lokelma is currently under regulatory review in the U.S., with a decision expected in the first half of 2018.

Advertisement

AstraZeneca has operations in northern Delaware.

Advertisement
Advertisement