Relypsa submits NDA for FDA clearance of hyperkalemia treatment Patiromer FOS

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

Relypsa president and chief executive officer John Orwin said the NDA submission for Patiromer FOS is an important milestone, which sets the stage for NDA acceptance and regulatory review of the company’s 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.

"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," Orwin said.

Hyperkalemia is a serious condition defined as abnormally elevated levels of potassium in the blood.

Relypsa chief medical officer Dr Lance Berman said the company believes 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."

Patiromer for Oral Suspension has been evaluated in CKD patients with hyperkalemia, including a two part Phase III program, a 12-month Phase II trial and a 48-hour Phase I onset-of-action trial.

The company said that in those trials, Patiromer FOS met its efficacy endpoints and the treatment was well tolerated.