Regulatory filing preparations underway for Vifor's PA21 on good Ph III results

The pivotal Phase III clinical study shows that the new phosphate binder PA21 successfully controls hyperphosphatemia in patients with chronic kidney disease on dialysis, reports Switzerland-based Vifor Pharma, part of the Galenica Group (SIX: GALN). PA21 is being developed in collaboration with Fresenius Medical Care.

The study investigated the use of PA21 (iron(III)-oxyhydroxide) in treating hyperphosphatemia in patients with chronic kidney disease (CKD) who are on dialysis. The study met its primary and secondary endpoints, and will be used as the basis for regulatory filings in the USA, Europe and Switzerland, with the first submission planned for the fourth quarter of this year, the company said.

PA21 is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron(III)-oxyhydroxide, starch and sucrose. Results of the six-month study with more than 1,000 patients conducted in the USA, Europe as well as in Russia, Ukraine and South Africa established the superiority of maintenance doses of PA21 versus a PA21 inactive low-dose in sustaining the phosphate-lowering effect in dialysis patients.