PA21 dossier submitted for approval to US FDA
Montag, 11. Februar 2013, ↓ direkt zum Download
The New Drug Application (NDA) for PA21 has been submitted to the US Food and Drug Administration (FDA). Separately, the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA), 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.
“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, Nephrologist, Professor at the North Shore University Health System, Evanston, Illinois, USA, and Investigator in the PA21 pivotal study. He stressed: “For the US nephrologists PA21 represents a welcome alternative for the management of hyperphosphatemia in dialysis patients especially due to the low pill burden as demonstrated in the pivotal study. Today, a high pill burden remains one of the major reasons for poor patient adherence and unsatisfactory serum phosphate control.”
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, meet its primary and secondary endpoints and serves 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, ein Unternehmen der Galenica Gruppe, ist eine der weltweit führenden Gesellschaften im Bereich Erforschung, Entwicklung, Herstellung und Vermarktung von pharmazeutischen Produkten zur Behandlung von Eisenmangel. Das Unternehmen bietet zudem ein diversifiziertes Portfolio an verschreibungspflichtigen Medikamenten und nicht verschreibungspflichtigen (OTC) Produkten an. Vifor Pharma mit Sitz in Zürich, Schweiz, baut seine globale Präsenz laufend aus und verfügt über ein umfassendes Netzwerk aus Tochtergesellschaften und Partnern weltweit.
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 (www.fmc-ag.com). It is also currently undergoing Phase II clinical development in Japan by Kissei Pharmaceuticals Co., Ltd.
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