FDA approves Lokelma ( sodium zirconium cyclosilicate )

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

LOKELMA is a drug for the treatment of hyperkalemia in adults.

Hyperkalemia is a condition in which the amount of potassium in the blood is too high.

How is this drug used?

LOKELMA is a powder that is mixed with water and taken three times a day for up to 48 hours. For patients needing continued treatment, the drug is taken once a day, with the dose adjusted as needed based on the amount of potassium in the blood.

What are the benefits of this drug?

LOKELMA reduced high levels of potassium in the blood and maintained the potassium at a normal level.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: LOKELMA worked similarly in men and women.
• Race: LOKELMA worked similarly in White and Blacks or African American patients. The number of patients in other races was limited; therefore, differences in response to LOKELMA among all races could not be determined.
• Age: LOKELMA worked similarly in patients below and above 65 years of age.