Novartis Global Communications CH-4002 Basel

• Main Authors: Corinne Hoff, John Gilardi
• Other Authors: The Pennsylvania State University CiteSeerX Archives
• Format: Text
• Language: English
• Subjects: Norway; Iceland
• Online Access: http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.557.9604; http://hugin.info/134323/R/990207/148798.pdf

Novartis receives European marketing authorization for Aclasta® First long-lasting treatment for Paget’s disease delivered as a 15 minute intravenous infusion Basel, April 21, 2005 – Novartis Pharma AG announced today that Aclasta ® (zoledronic acid 5mg solution for infusion) has been granted Marketing Authorization by the European Commission for the treatment of Paget’s disease of the bone in all 25 European member states, as well as Norway and Iceland. This represents the first approval for Aclasta. In a head-to-head comparison versus the commonly used oral bisphosphonate risedronate, a single, 15 minute IV infusion of Aclasta showed superior efficacy1 and faster onset of action2, with longer remission following a single dose.3 Aclasta’s unique molecular structure and IV administration enable fast and enduring efficacy.1 Aclasta, in clinical trials, was found to be generally safe and well tolerated.4 Bisphosphonates are well established as the standard of care for Paget’s disease. However, oral risedronate requires daily administration for two months and for patients to avoid eating or drinking for 30 minutes prior to intake.5