22 October 2014 - Relypsa, Inc., today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market patiromer for oral suspension (Patiromer FOS) for the treatment of hyperkalaemia, a serious condition defined as abnormally elevated levels of potassium in the blood.

The NDA is supported by eight clinical trials, including a Phase III program that was conducted under a Special Protocol Assessment as well as a Phase II trial that evaluated Patiromer FOS in patients for up to one year.

"Our submission of the NDA for Patiromer FOS is an important milestone, which sets the stage for NDA acceptance and regulatory review of our application and ultimately, potential approval of the drug and potentially marking the first new therapeutic innovation available to treat patients with hyperkalemia in over 50 years," said John A. Orwin, president and chief executive officer of Relypsa. "We look forward to offering patients a potential treatment for hyperkalemia that can normalize their potassium levels in acute and chronic settings. Based on the efficacy and safety of twice daily dosing demonstrated in clinical studies, as well as the early onset of action and favorable safety profile for up to one year, we believe that Patiromer FOS has the potential to become a preferred treatment option for hyperkalemia."

For more details, go to: http://investor.relypsa.com/releasedetail.cfm?ReleaseID=877474