EU approves label update for AstraZeneca's Lokelma

Pharma Times

4 May 2020 - European regulators have approved a label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalaemia in patients with end-stage renal disease on stable haemodialysis.

The decision rides on the back of findings from the Phase IIIb DIALIZE trial, which AZ says is the first-ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis.

Data showed that a significantly higher proportion of patients in the Lokelma group (41.2%) met the primary endpoint and were classified as responders compared to patients in the placebo group (1.0%).

Read Pharma Times article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Outcome , Medicine , Europe , Regulation