Regulatory compliance standardsVifor Fresenius Medical Care Renal Pharma (VFMCRP), a common company of Galenica and Fresenius Medical Care, and Relypsa, Inc., a biopharmaceutical company, have announced that VFMCRP has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Patiromer.

VFMCRP is seeking approval of Patiromer (US brand name: Veltassa) for the treatment of hyperkalaemia, or elevated blood potassium levels, in the European Union (EU) through the EU centralized procedure.

Patiromer was approved by the US Food and Drug Administration (FDA) for the treatment of hyperkalaemia in the US in October 2015 under the name Veltassa, becoming the first new medicine in more than 50 years for people with elevated serum potassium.

“The MAA submission for Patiromer represents an important milestone in our efforts to bring hyperkalaemia 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 programme that included many patients from Europe.” 

“As a recognized global leader in nephrology, VFMCRP shares our commitment to bringing Veltassa to hyperkalaemia patients around the world,” said John A. Orwin, President and Chief executive officer of Relypsa. “This MAA submission brings us another step closer to achieving that goal for people with hyperkalaemia in Europe.”

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

  • Pivotal Phase III OPAL-HK study, which was conducted under a FDA Special Protocol Assessment, and evaluated Patiromer in hyperkalaemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors
  • Phase II AMETHYST-DN trial, which evaluated the use of Patiromer for 52 weeks in hyperkalaemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors
  • An open-label, uncontrolled, Phase I 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 2016 by the EMA. After this period, an official regulatory review will be undertaken.