The FDA approved patiromer (Veltassa) to treat patients with hyperkalemia, which typically occurs in patients with heart failure or kidney disease.
It is the first new medicine to treat hyperkalemia in more than 50 years, according to Relypsa, Inc., which markets and manufactures the drug. The drug is expected to be available in the U.S. in the first week of January 2016.
Patiromer is a powdered medication that patients mix with water and take orally. Approximately three million people in the U.S. have hyperkalemia, which is defined as elevated blood potassium levels and can cause abnormal heart rhythms or sudden death.
The approval was based on trials of patients with heart failure, chronic kidney disease, diabetes, hypertension and others who commonly have high blood potassium. Patients who received patiromer lowered their potassium levels.
The most common adverse events in the trials were constipation (7.2 percent of patients), hypomagnesemia (5.3 percent), diarrhea (4.8 percent), nausea (2.3 percent), abdominal discomfort (2.0 percent) and flatulence (2.0 percent).
A boxed warning recommends that if patients take patiromer and an oral medication, they should take them at least six hours apart because patiromer binds to other oral drugs. The medication is dispensed with a medication guide describing information about risks of the drug.