Novartis Pharma's 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 isphosphonate risedronate, a single, 15 minute IV infusion of Aclasta showed superior efficacy and faster onset of action, with longer remission following a single dose. Aclasta unique molecular structure and IV administration enable fast and enduring efficacy.

Aclasta, in clinical trials, was found to be Bisphosphonates are well established as the standard of care for Paget disease. However, oral risedronate requires daily administration for two months and for patients to avoid eating. Oral bisphosphonates have limitations as not everyone responds well to them, or respond only very slowly and many relapse over time. In addition, they require complex administration regimens and are often associated with gastrointestinal discomfort, which can lead to poor compliance.

"The availability of a single intravenous infusion such as Aclasta that demonstrated superior efficacy, faster onset of action and longer remission in clinical studies compared to risedronate will be welcomed by patients and physicians," commented Professor Johann D Ringe, Klinikum Leverkusen, Germany.

Paget's disease, the second most common metabolic bone disease after osteoporosis, can lead to serious consequences if not treated appropriately. It is a chronic skeletal disorder which in many patients causes pain, fractures and deformities that can seriously impede their ability to perform routine activities of daily living.