PA21 authorisation application submitted in Switzerland
Tuesday, 12 March 2013, ↓ directly to download
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 United States, 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 emphasized: “Today, our patients have to take on average 9 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 3 to 4 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 optimize 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.
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
PA21 is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches. Each tablet of PA21 contains the equivalent of 500mg of iron. When taken with meals, PA21 adsorbs the dietary phosphate in the gastrointestinal tract and preventing its uptake into the blood. The adsorbed phosphate is subsequently eliminated through the faeces.
PA21’s prior Phase II clinical trial met both its primary and secondary endpoints. The serum phosphorus lowering efficacy of the two lowest active doses was numerically comparable to 4.8g/day sevelamer hydrochloride. PA21 was also well tolerated, with a comparable overall safety and tolerability profile.
The Phase III trial was an open-label, randomised, active controlled, parallel group study to investigate the safety and efficacy of PA21 compared to sevelamer carbonate, followed by a randomized comparison of PA21 maintenance dose versus PA21 inactive low-dose in dialysis patients with hyperphosphatemia. It was followed by a six-month safety extension study.
PA21 is developed in collaboration with Fresenius Medical Care. It is also currently undergoing Phase II clinical development in Japan by Kissei Pharmaceuticals Co., Ltd.
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