New medicines
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Relypsa have submitted Marketing Authorisation Application (MAA) requesting European approval of patiromer for the treatment of hyperkalemia.

Patiromer was previously approved by the US Food and Drug Administration (FDA) for the treatment of hyperkalemia in the US in October 2015, under the brand name Veltassa. As a result, it became the first new medicine in more than 50 years for people with elevated serum potassium.

The European submission for patiromer is supported by data from a comprehensive clinical development program that included the following studies:

  • Pivotal Phase 3 OPAL-HK study, which was conducted under a FDA Special Protocol Assessment, and evaluated patiromer in hyperkalemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors
  • Phase 2 AMETHYST-DN trial, which evaluated the use of patiromer over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors
  • An open-label, uncontrolled, Phase 1 study that evaluated the onset-of-action of patiromer hyperkalemic CKD patients.
 The European submission will undergo a formal acceptance and validation phase during May by the EMA. After this period, an official regulatory review will be undertaken.

“The MAA submission for patiromer represents an important milestone in our efforts to bring hyperkalemia patients in Europe a new treatment option as soon as possible,” said Stefan Schulze, chief executive officer of VFMCRP. “Relypsa has been an excellent partner supporting the preparation of this robust submission, which is based on positive efficacy and safety results from an extensive clinical development program that included many patients from Europe."

John A. Orwin, president and chief executive officer of Relypsa, said: “As a recognised global leader in nephrology, VFMCRP shares our commitment to bringing Veltassa to hyperkalemia patients around the world. 

"This MAA submission brings us another step closer to achieving that goal for people with hyperkalemia in Europe."