2015 | HFSA

Relypsa Announces FDA Approval of Veltassa

Practice News

Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VeltassaTM (patiromer) for oral suspension, a new polymer medicine that binds potassium, for the treatment of hyperkalemia.

"We are very excited to bring people with hyperkalemia the first new medicine in more than 50 years," said John A. Orwin, president and chief executive officer of Relypsa. "The FDA approval of Veltassa represents approximately a decade of research by dedicated scientists and doctors, and underscores Relypsa's commitment to developing polymer-based treatments for people with conditions that are often overlooked and undertreated. We would like to thank the many clinical trial investigators and patients who contributed to the development of this important medicine that may help the millions of people affected by hyperkalemia."

"As the number of people with CKD and heart failure continues to climb, hyperkalemia is a challenge doctors and patients need to be aware of," said Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine and the lead investigator for the pivotal Phase 3 clinical trial of Veltassa. "Veltassa will provide doctors and patients a new medicine for daily treatment of hyperkalemia, which has been shown to be effective in correcting blood potassium and can be used chronically to keep levels in the target range."

For the full press release from Relypsa, please go here.