FDA Approves Drug to Treat Hyperkalemia

The drug fills a void for patients with chronic kidney disease, including those with diabetes, who have high potassium levels.

Today, the FDA approved patiromer for oral suspension, to be marketed as Veltassa, to treat hyperkalemia, which results when potassium levels in the blood become too high.

The drug fills a void to treat roughly 3 million people who experience the build-up of potassium in the blood that places them at greater risk of heart arrhythmia.

Patiromer, a powder that mixes with water to create a tasteless, odorless liquid that patients drink once a day, brings potassium under control, giving kidney and heart disease patients the ability to be treated with RAAS inhibitors. The thought is that by using patiromer, patients will be able to take RAAS inhibitors and keep kidney disease from progressing, thus avoiding dialysis.

The drug is of interest to those with chronic kidney disease, including those with diabetes.

In approving patiromer, FDA’s Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the Center for Drug and Evaluation Research, said, “Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm. It’s important to have treatment options for hyperkalemia available to patients.”

The drug works by binding potassium in the gastrointestinal tract; the potassium is then exited from the body through the normal excretion process. The most common adverse reactions in clinical trials were constipation, decreased magnesium levels in the blood, diarrhea, nausea, flatulence, and abdominal discomfort.

Patiromer carries a boxed warning because it binds with other orally administered drugs, which could decrease their absorption and reduce their effects. Other drugs should be taken 6 hours apart from patiromer.

The drug is manufactured by Relypsa.