FDA Approves Lokelma for Hyperkalemia

The US Food and Drug Administration (FDA) has approved sodium zirconium cyclosilicate (Lokelma, AstraZeneca) — a medication that rapidly restores normal potassium levels — for adults with hyperkalemia.

Formerly known as ZS-9, the drug is a “highly-selective, oral potassium-removing agent,” the company explains in a company news release.

Hyperkalemia has become a significant problem.  With more type 2 Diabetes Mellitus, we are seeing an explosion of chronic kidney disease.  In patients with CKD 3b and 4, patients often develop hyporenin, hypoaldosterone and thus type IV RTA.  However, many patients have relative hyporenin and therefore decreased angiotensin 1.  When these patients take an ACE inhibitor or and ARB, they develop hyperkalemia because of inadequate aldosterone.

And these patients have an absolute indication for an ACE-I or ARB.  Thus, we have a conundrum.  How do we successfully treat their systolic dysfunction or progressive CKD.

Drug companies see an niche.  Sodium polysterene (Kayexalate) is not adequate due to dangerous side effects.  Patiromer (Valtessa) was released first, now this new option.

What will be their roles?  What will be the pricing?

This is all interesting, and we will follow the indications for its use with interest.