Vifor Fresenius PA21 filed for approval with US FDA, accepted by EMA

A New Drug Application for PA21 (iron(III)-oxyhydroxide) has been submitted to the US Food and Drug Administration. Separately, the European Medicines Agency has accepted the Marketing Authorization Application, which was submitted in December 2012 to seek approval in the European Union. The filing for Singapore was submitted at the beginning of 2013 and further submissions for approval are being prepared.

The new phosphate binder PA21 was developed by Switzerland-based Vifor Pharma, a subsidiary of Galenica Group (GALN: SIX). In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a joint venture of Galenica and Fresenius Medical Care.

"Efficacy and safety of PA21 have clearly been demonstrated in a large Phase III study that included more than 1,000 patients," commented Stuart Sprague, a nephrologist and Professor at the North Shore University Health System, Evanston, Illinois, USA, and investigator in the PA21 pivotal study.