PA21 dossier sent for submission to EMA to seek approval in the EU
Thursday, 20 December 2012, ↓ directly to download
In July 2012, the pivotal phase III study of PA21 was successfully completed: it met its primary and secondary endpoints and therefore served as a basis for the registration filings. The first approval dossier has now been finalised and dispatched for submission to the European Medi-cines Agency (EMA). Further submissions for approval are being prepared for the US, Switzer-land and Singapore.
The data from the phase III study of PA21, published in July 2012, demonstrated that the new phos-phate binder successfully controls hyperphosphataemia in patients with chronic kidney disease (CKD). PA21 was shown to be generally well-tolerated and efficacious with the advantage of a low pill burden. 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 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 Medi-cal Care. With the support of Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma expedited the preparation of the registration filing so that the first dossier was dispatched to the European Medicines Agency (EMA) in December 2012. This submission will undergo a formal acceptance and validation phase during January 2013 by the EMA. After this period, an official regulatory review will be undertaken.
Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).
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Head of Corporate Communications