The European Commission has approved the Marketing Authorization Application for Veltassa (patiromer) to treat hyperkalemia. Veltassa is approved for marketing in all 28 EU countries and in Iceland, Liechtenstein and Norway. Vifor Pharma Group said it plans to launch Veltassa in Europe by the end of 2017 or in early 2018.
“The European approval of Veltassa marks the first regulatory approval for this important medicine outside the U.S., further validating our innovative polymer science.” said Scott Garland, president of Relypsa. “In the 18 months since we launched Veltassa, more than 33,000 patients with hyperkalemia, a serious and often chronic health concern, have been treated with it.”
The U.S. Food and Drug Administration approved Veltassa in October 2015. Marketing authorization applications for Veltassa have been submitted and are under review in Switzerland and Australia. Vifor Pharma said it plans to submit applications in other markets worldwide.