FDA Accepts Relypsa's NDA For Patiromer In Hyperkalemia

Relypsa reported that its New Drug Application (NDA) for its drug Patiromer for Oral Suspension (Patiromer FOS) as treatment for hyperkalemia has been accepted by the U.S. Food and Drug Administration (FDA).

Patiromer is a high capacity, oral potassium binder under development as treatment for hyperkalemia. The drug has been tested in patients with chronic kidney disease (CKD) with hyperkalemia, including an early stage onset-of-action study, a 12-month Phase 2 trial, and a two-part Phase 3 study. The company reported that the drug met all of its efficacy endpoints  in the trials. The pivotal clinical study for Patiromer FOS was facilitated under an FDA Special Protocol Assessment.

Relypsa's NDA filing was supported by eight clinical trials, including a long-term treatment Phase 3 trial that showed the drug's efficacy in lowering potassium in patients with hyperkalemia. Last month Relypsa announced that it published data from the pivotal Phase 3 study in the New England Journal of Medicine.

John A. Orwin, President and CEO, said, "Acceptance of our NDA is a significant milestone... We also believe there is a significant unmet medical need for patients, particularly as it relates to chronic therapy, and we are planning for broad access to the drug. Based on the robust data, which demonstrated the early onset of action and favorable safety profile for up to one year, we believe that Patiromer FOS, if approved, will become an important new treatment option for patients with hyperkalemia." 

Hyperkalemia is a serious condition marked by abnormally elevated levels of potassium in the blood that can lead to fatal cardiac arrhythmia and sudden death. Hyperkalemia usually affects patients who suffer from chronic kidney disease, diabetes, hypertension, and/or heart failure. CKD patients or those with heart failure treated with  renin-angiotensin-aldosterone-system (RAAS) inhibitors, such as ARBs (Angiotensin Receptor Blockers), AAs (Aldosterone Antagonists), and ACE (Angiotensin-Converting-Enzyme) inhibitors are at heightened risk of developing hyperkalemia.

Relypsa submitted its NDA for Patiromer with the FDA in October this year. The company said it anticipates regulatory activities in connection with its NDA to start in early January next year.