FDA Approves Relypsa’s Hyperkalemia Therapy Veltassa
The FDA last week approved Relypsa’s hyperkalemia therapy Veltassa — the company’s first product and the first advance in treating the life-threatening condition in more than five decades.
Veltassa (patiromer for oral suspension) is a powdered medication that patients mix with water and drink to decrease the absorption of potassium into the bloodstream.
Approval was based on eight clinical trials, including two Phase 3 studies that showed that patients taking Veltassa had no change in median potassium from baseline, compared with the placebo group, which saw their potassium increase significantly.
The only other available treatment for hyperkalemia is Concordia Healthcare’s Kayexalate (sodium polystyrene sulfonate), which was approved by the FDA in 1958. However, that drug causes severe constipation, a side effect Veltassa also has, but in a milder form.
Calif.-based Relypsa did not respond to request regarding its launch plans for Veltassa. — Kellen Owings