Relypsa announced that the Food and Drug Administration (FDA) has approved Veltassa (patiromer) for oral suspension, indicated for the treatment of hyperkalemia.
The approval is based on clinical trials which showed that Veltassa significantly decreased potassium levels in hyperkalemic patients, including those with chronic kidney disease (CKD), heart failure, diabetes, and hypertension.
Veltassa is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion. It increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.
Veltassa was approved with a Boxed Warning recommending that other oral medications should be administered at least 6 hours before or after Veltassa due to the potential for Veltassa to bind to other medications, decrease gastrointestinal absorption, and reduce efficacy.
Veltassa is supplied as 8.4g, 16.8g, or 25.2g single-use packets in 4- or 30-packet cartons. It is expected to launch in January 2016.
For more information visit Relypsa.com.