AstraZeneca’s hyperkalaemia therapy Lokelma has picked up a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), bringing it one step closer to European licensing.
It has been recommended for use in adult patients with hyperkalaemia, and would be made available as a 5g or 10g orally-administered treatment.
Backing from the CHMP came on the back of clinical trials of over 1,600 patients, which showed significantly reduced or normal levels of blood serum potassium within 48 hours, lasting up to 28 days.
Lokelma (sodium zirconium cyclosilicate) is a potassium-binding compound designed to reduce excessive levels of serum potassium by drawing it into the gastrointestinal tract.
The drug was originally developed by ZS Pharma, which described Lokelma as a “potential best-in-class treatment” and tipped it as a potential blockbuster.
AstraZeneca acquired the pharma firm in a $7.2bn deal at the end of 2015 to get access to the drug, however faced a shock setback last May when it was rejected by the FDA due to manufacturing issues.
Not required to provide new clinical trial data, it was resubmitted for US approval in October last year and the company expects a decision from the FDA in the first half of this year.
Hyperkalaemia is commonly associated with chronic heart failure and chronic kidney disease, and carries risk of potentially fatal cardiac arrhythmias.
Speaking at the time of ZS Pharma’s acquisition, AstraZeneca’s chief executive Pascal Soriot said the risk of hyperkalaemia “is underappreciated and prevalence is increasing”.