FDA Increases Dosing Flexibility of Hyperkalemia Drug

The US Food and Drug Administration has approved a supplemental new drug application for the use of the drug Veltassa (patiromer) with or without food for the treatment of hyperkalemia.

The approval was granted after the completion of the Phase 4 TOURMALINE study (n = 114). Results of the study demonstrated that there were no significant differences in achieving serum potassium levels within the target range of 3.8 to 5.0 mEq/L between participants who took Veltassa with or without food.

These results remained consistent when assessed by baseline potassium, race, estimated glomerular filtration rate. and type 2 diabetes. Rates of adverse events were consistent between groups as well.

Veltassa was first approved by the FDA for the treatment of hyperkalemia in October 2015.

—Christina Vogt

Reference:

Relypsa announces FDA approval of supplemental new drug application to enable the usage of Veltassa (patiromer) with or without food [press release]. Redwood City, CA. Relypsa, Inc. May 8, 2018 http://www.relypsa.com/newsroom/press-releases/050818/ Accessed on May 9, 2018.