Relypsa Submits New Drug Application To U.S. FDA Seeking Approval For Patiromer For Oral Suspension To Treat Hyperkalemia

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 hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood. The NDA is supported by eight clinical trials, including a Phase 3 program that was conducted under a Special Protocol Assessment as well as a Phase 2 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." Lance Berman, chief medical officer of Relypsa added, "We believe that the clinical development program for Patiromer FOS is the first to provide robust clinical data for the evaluation of efficacy of a therapy for the treatment of hyperkalemia. To our knowledge, Patiromer FOS is the first therapy to date that has successfully completed a prospective 12-month evaluation of safety, efficacy and tolerability in a long term, chronic treatment setting in hyperkalemic patients."