PDUFA action date for PA21 New Drug Application set by US FDA

(PresseBox) ( Bern, )
Following the submission of the New Drug Application (NDA) for PA21, the US Food and Drug Administration (FDA) has announced that it has accepted the filing and assigned a PDUFA (Prescription Drug User Fee Act) target action date of 1 December 2013 to complete its review.

PA21 is a chewable, iron-based phosphate binder for the control of hyperphosphatemia in patients with chronic kidney disease (CKD). Pivotal Phase III data demonstrated that this new phosphate binder successfully controls hyperphosphatemia in patients with CKD with the advantage of a low pill burden.

The European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) for review on the 30 January 2013 seeking approval in the European Union. PA21 has also been filed for approval in Singapore and Switzerland and further submissions for approval are being prepared.

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.

A PDUFA action date is a target for the FDA to complete its review of the drug. The FDA does not commit to complete the review by this date.

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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