my.bionity.com
With an accout for my.bionity.com you can always see everything at a glance – and you can configure your own website and individual newsletter.
03-05-2011: Keryx Biopharmaceuticals, Inc. announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) for the development of Zerenex™ (ferric citrate) for the management and control of serum phosphorus in end-stage renal disease (ESRD) patients undergoing dialysis, and in pre-dialysis chronic kidney disease patients (CKD). The Scientific Advice from the EMA indicates that the Company's current Phase 3 program in the United States, if successful, in conjunction with safety data generated from other clinical studies with Zerenex, is considered sufficient to support a European marketing authorization application (MAA) to the EMA for the indication in ESRD patients on dialysis. Therefore, the Company believes that it will not need to conduct any additional clinical trials with Zerenex in order to obtain European approval in the dialysis setting.
The Scientific Advice has also provided the Company with a regulatory path forward in the pre-dialysis CKD setting in Europe.
Ron Bentsur, Chief Executive Officer of Keryx, stated, "The EMA's Scientific Advice for Zerenex represents a significant step toward the registration of Zerenex in Europe, which we believe would put European approval on a similar timetable as U.S. approval." Mr. Bentsur continued, "In addition to the dialysis setting, with a clear regulatory path forward in the pre-dialysis CKD setting, we believe we now have an opportunity to fully capitalize on the significant global market for phosphate binders." Mr. Bentsur added, "We wish to thank the EMA's Scientific Advice Working Party for their input and guidance."
Zerenex (ferric citrate), a ferric iron-based phosphate binder, is currently in Phase 3 clinical development in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis which is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Contact / Request information
Request further information free of charge:
Watchlist
This is where you can add this news to your personal favourites
Keryx Biopharmaceuticals, Inc. announced the initiation of a Phase 2 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidn ... more
Keryx Biopharmaceuticals Announces Positive Top-Line Results from Phase 3 Study of Ferric Citrate
Keryx Biopharmaceuticals, Inc. announced that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has announced positive top-line results from a Phase 3 study of ferric citrate in Japan for the treatment of hyperphosphatemia in end-stage renal disease p ... more
Keryx Biopharmaceuticals, Inc. announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) for the development of Zerenex™ (ferric citrate) for the management and control of serum phosphorus in end-stage renal disease (ESRD) patients undergoing dialysi ... more
Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron ... more
The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutic ... more
Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh
Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-co ... more
European Medicines Agency publishes 2012 annual report
The European Medicines Agency has published its 2012 annual report. The report highlights the main trends recently observed in the Agency’s activities. For the past few years, the Agency has received a stable number of initial marketing authorisation applications (MAAs) for human medicines, ... more
European Medicines Agency (EMA)
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. more
Über CHEMIE.DE
CHEMIE.DE Information Service GmbH runs specialist scientific internet portals. The secret to our success? We are familiar with what we publish.
Advertising at CHEMIE.DE
Our advertising formats support you in getting your message across to a clearly defined target audience.
© 1997-2013 CHEMIE.DE Information Service GmbH, All rights reserved
Netmeeting
