FDA approves Veltassa to treat hyperkalemia

FDA has approved patiromer (Veltassa, Relypsa) for oral suspension, a new polymer drug that binds potassium, for the treatment of hyperkalemia.

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Hyperkalemia, which refers to a blood potassium level that is higher than normal, can cause abnormal heart rhythms and even sudden death. Approximately 3 million Americans with stage 3 or 4 chronic kidney disease (CKD) or heart failure have hyperkalemia. Potassium is critical to the function of nerve and muscle cells in the body, including those in the heart. The kidneys remove potassium from the blood to maintain a normal level in the body, but when the kidneys do not remove potassium properly, the level can get too high. 

Veltassa is a potassium binder indicated for the treatment of hyperkalemia that works by increasing potassium excretion through binding of potassium in the gastrointestinal tract, which reduces the concentration in the gastrointestinal lumen, resulting in a reduced serum potassium level. The drug comes as a powered medication that patients mix with water and take by mouth once-a-day with food.

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"As the number of people with CKD and heart failure continues to climb, hyperkalemia is a challenge doctors and patients need to be aware of," said Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine and the lead investigator for the pivotal phase 3 clinical trial of Veltassa. "Veltassa will provide doctors and patients a new medicine for daily treatment of hyperkalemia, which has been shown to be effective in correcting blood potassium and can be used chronically to keep levels in the target range."

FDA's approval of Veltassa was based on results from clinical trials that studied patients who are representative of people who typically experience hyperkalemia, including those with CKD, heart failure, diabetes, and hypertension. In the trials, Veltassa significantly reduced and maintained serum potassium levels for up to a year in patients with hyperkalemia.

Constipation, low serum magnesium levels, diarrhea, nausea, abdominal discomfort and flatulence are the most common adverse effects associated with the use of Veltassa.

Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia due to its delayed onset of action. The drug also has a boxed warning because it binds many other oral medications, which could decrease their absorption. It is recommended to take Veltassa and any other orally administered medications at least 6 hours apart.

Veltassa is expected to be available to patients in the United States by the first week of January 2016. 

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