The F.D.A. Has Approved a New Label For a Hyperkalemia Treatment

The U.S. Food and Drug Administration (FDA) has approved a new use for the treatment Veltassa (patiromer) as an oral suspension (liquid form of the drug) to treat hyperkalemia, a term used to describe high blood potassium levels. The full press release can be read here, at Pharmaceutical Business Review.
The FDA had previously approved Veltassa in 2016. They have now also approved a supplemental new drug application, which is used when manufacturers want to market a new dosage, change the label, or change the manufacturing process. Scott Garland, the president of Relypsa (the company behind the drug), said he hopes

this new approval “will provide patients with greater flexibility.”

Hyperkalemia, or high blood potassium levels, is associated with several different conditions. Most commonly, it is caused by changes in kidneys from conditions such as chronic kidney disease and acute kidney failure. However, other conditions including Addison’s disease, Type 1 diabetes, severe injuries, and dehydration can also lead to hyperkalemia. Certain medications such as beta-blockers, ACE inhibitors, and angiotensin II receptor blockers have also been linked to it. Hyperkalemia is usually only discovered after a doctor orders a blood test, and fast treatment is important. The condition can lead to serious symptoms such as weakness, paralysis, muscle fatigue, nausea, and an abnormal heartbeat.

Veltassa has been shown to be effective at treating the condition, and the FDA approval follows a Phase 4 study of the drug. The research was carried out over 29 US sites and on 112 patients, 62% of who had stage 3b-5 non-dialysis chronic kidney disease. The patients all took Veltassa once per day and were randomly assigned to take it either with or without food. Researchers found no significant differences between the ‘with food’ and ‘without food’ groups in the number of patients that achieved potassium levels in the target range.
The study lasted for six weeks; patients received the drug for four weeks and were followed up by researchers for a subsequent two. It was found that by week four 87% of patients taking Veltassa with food and 83% of the group taking it without food has reached potassium blood levels within the range aimed at. Those who began the study with higher potassium blood levels generally saw the greatest reductions.
The FDA’s approval of the new use of Veltassa will allow patients more choice in their treatment of hyperkalemia.

Anna Hewitt

Anna Hewitt

Anna is from England and recently finished her undergraduate degree. She has an interest in medicine and enjoys writing. In her spare time she likes to cook, hike, and hang out with cats.

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