Relypsa Announces Assignment of October 21, 2015 PDUFA Date for New Drug Application for Patiromer for Oral Suspension

Relypsa, Inc.

, today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015 for completion of the review of the New Drug Application (NDA) for the investigational agent 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 company had announced on December 15, 2014 that the FDA accepted the Patiromer FOS NDA for review. In the day-74 letter to Relypsa, the FDA further indicated that it does not currently plan to convene an Advisory Committee for advice on the company's NDA. If approved, Patiromer FOS is expected to be the first new therapeutic made available for the treatment of hyperkalemia in over 50 years. "There are limited options for the treatment of hyperkalemia, a condition that affects many people with chronic kidney disease and heart failure and may be further exacerbated in patients on renin-angiotensin-aldosterone-system (RAAS) inhibitors," said John A. Orwin, president and chief executive officer of Relypsa. "We are pleased that the NDA is considered filed by FDA and look forward to potentially offering patients and physicians a new treatment option that has been evaluated in acute and chronic settings." The NDA is supported by eight clinical trials, including a Phase 3 program that was conducted under a Special Protocol Assessment, a long-term treatment trial that evaluated the safety and efficacy of Patiromer FOS in patients for up to one year, and an onset-of-action study that evaluated the time to potassium lowering action. The company also announced that it will host and webcast an Analyst Day to be held in New York on Thursday, January 8, 2015 at 9:00 a.m. ET. Interested parties may access the live webcast and subsequent archived recording by visiting the Investor Events section of Relypsa's website at www.relypsa.com.