Relypsa Submits NDA For Patiromer In Hyperkalemia
By Cyndi Root
Relypsa has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for patiromer in the treatment of hyperkalemia. The company announced the application in a press release, stating that the novel polymer treats abnormally elevated levels of potassium in the blood. Relypsa named Patheon in September 2014 as its intended manufacturer for the finished product, Lanxess as the API supplier, and DSM for additional manufacturing upon patiromer approval.
Lance Berman, CMO of Relypsa, said, “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."
Patiromer
Patiromer (RLY5016 for Oral Suspension) is an oral potassium binder. In trials for Chronic Kidney Disease (CKD) in patients with hyperkalemia, patiromer reduced elevated levels of blood potassium, and patients found it tolerable. Current CKD treatments consist of RAAS inhibitors that delay end stage renal disease, however in hyperkalemia, the patient’s condition can worsen with RAAS inhibitors. Relypsa states that patiromer also shows promise in heart failure patients with hyperkalemia. In September 2014, Relypsa announced in a press release that a Phase 3 study of patiromer showed that the agent rapidly corrected hyperkalemia and prevented recurrence in heart failure patients as well as non-heart failure patients.
Relypsa has supported its NDA with eight clinical trials. John A. Orwin, president and CEO of Relypsa, said that based on the twice daily dosing in the clinical studies, early onset of action, and the favorable safety profile, his company believes patiromer could become a first-line treatment for hyperkalemia.
About Relypsa
Relypsa is headquartered in Redwood City, CA, close to San Francisco. The company has protected its lead product candidate, Patiromer for Oral Suspension, with intellectual property rights until at least 2030. Relypsa has another candidate in development, RLY6002, currently in preclinical testing as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The company is actively seeking partners for in-licensing of external technologies and out-licensing of internal technologies. The company states that its infrastructure supports collaborations in the U.S., but it would welcome partners worldwide.