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FDA approves Relypsa's hyperkalemia drug
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The U.S. Food and Drug Administration has approved Relypsa, Inc.'s Veltassa (patiromer for oral suspension) to treat hyperkalemia. Veltassa is the first new medicine to treat hyperkalemia in more than 50 years.
In clinical trials, Veltassa was effective in lowering potassium levels in hyperkalemic participants with chronic kidney disease on at least one drug that inhibited the renin-angiotensin-aldosterone system. The clinical development program studied patients who are representative of people who typically experience high blood potassium levels, including people who had CKD, heart failure, diabetes and hypertension.
Veltassa is a powdered medication that patients mix with water and take by mouth. It is made of small smooth spherical beads, about one-tenth of a millimeter in diameter—the size of a typical dust particle. When mixed with a few tablespoons of water and swallowed, these particles attach themselves to potassium ions in the lower part of the colon, where the concentration of free potassium is the highest. The potassium-packed beads are then excreted.
Relypsa said that they expect to make Veltassa available to patients in the United States by the first week of January 2016.
Veltassa has a boxed warning because it binds many other orally administered drugs, which could decrease their absorption and reduce their effects. The warning recommends taking it and any other orally administered medication at least six hours apart. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
For more information regarding the availability of Veltassa and the patient support program, patients and doctors can call 844.870.7597.