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.