PA 21( Galencia) is filed at FDA and EMA for treatment of Hyperphosphataemia in CKD patients
A New Drug Application (NDA) for PA21 from Fresenius Kabi/Galencia has been submitted to the FDA. Separately, the European Medicines Agency has accepted the Marketing Authorisation Application which was submitted December 2012 to seek approval in the European Union. Further submissions for approval are being prepared.
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, meets 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.
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