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An application for the authorisation of PA21 in Switzerland has been submitted to the Swiss Agency for Therapeutic Products (Swissmedic). The application in Switzerland follows the recent submission of a New Drug Application for PA21 in the US, acceptance of the Marketing Authorisation Application by the European Medicines Agency (EMA) in the European Union and a regulatory submission in Singapore.
“Management of hyperphosphatemia in dialysis patients remains a challenge due to insufficient patient adherence. PA21 has the potential to improve patient adherence and phosphate control by offering a high phosphate binding capacity with a low pill burden,” commented Rudolf P. Wüthrich, Professor of Nephrology at the University of Zurich, Switzerland, and an Investigator in the PA21 development program. He emphasised: “Today, our patients have to take on average nine pills of phosphate binders daily. It is a lot, considering the significant amount of additional tablets taken by dialysis patients every day. A reduction of the pill burden to three to four pills per day, as a large phase III study with PA21 has recently demonstrated, may lead to a better acceptance of treatment by dialysis patients and help nephrologists to optimise serum phosphate control in patients with end stage renal disease.”
PA21 is a chewable, iron-based phosphate binder for the control of hyperphosphatemia in patients with chronic kidney disease (CKD). The pivotal Phase III study was successfully completed in July 2012, meeting its primary and secondary endpoints and serving as the basis for registration filings in markets around the world. The data demonstrated that the new phosphate binder successfully controls hyperphosphatemia in patients with CKD. Full results from the phase III study were presented at the American Society of Nephrology (ASN) Kidney Week in San Diego, California, in November 2012. Results will also be submitted to peer-review journals.
The six months extension of the pivotal Phase III study has also been completed recently. Preliminary results show that the safety and efficacy of PA21 are maintained with the advantage of a low pill burden. These results will be submitted for presentation at the 50th ERA-EDTA (European Renal Association – European Dialysis and Transplant Association) congress, taking place in Istanbul, Turkey, in May 2013.
The new phosphate binder PA21 was developed by Vifor Pharma. In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care.
