Veltassa files for European approval
Swiss firm Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for Veltassa (patiromer) for oral suspension.
VFMCRP, a joint venture of Vifor parent company Galenica and Fresenius Medical Care, is seeking approval of Veltassa for the treatment of hyperkalemia, or elevated blood potassium levels, in the European Union through the EU centralized procedure. Last August, the company gained exclusive marketing right for Veltassa from US biotech firm Relypsa (Nasdaq: RLYP) in worldwide territories except the USA and Japan, where Relypsa retains all commercial rights. Relypsa and VFMCRP are currently collaborating on ongoing development of Veltassa.
Veltassa was approved by the US Food and Drug Administration for the treatment of hyperkalemia on October 21, 2015, becoming the first new medicine in more than 50 years for people with elevated serum potassium.
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