Veltassa (patiromer) filed with EMA for hyperkalemia- Vifor Fresenius Medical Care Renal Pharma

Vifor Fresenius Medical Care Renal Pharma announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Veltassa (patiromer) for oral suspension for the treatment of hyperkalemia, or elevated blood potassium levels, in the European Union through the EU centralized procedure.

The European submission for Veltassa is supported by data from a comprehensive clinical development program that included the pivotal Phase III OPAL-HK study, which was conducted under a FDA Special Protocol Assessment and evaluated Veltassa in hyperkalemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors. It also included the Phase II AMETHYST-DN trial, which evaluated the use of Veltassa over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors, and an open-label, uncontrolled, Phase I study that evaluated the onset-of-action of Veltassa in hyperkalemic CKD patients.

Comment: The European submission will undergo a formal acceptance and validation phase by the EMA during May 2016. Veltassa was approved by the FDA for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first new medicine in more than 50 years for people with elevated serum potassium.