Novartis says that Aclasta (zoledronic acid) has won its first approval for the treatment of Paget’s bone disease in all 25 of the European Union member states as well as Norway and Iceland.
The Swiss company notes that a 15-minute infusion of Aclasta showed superior efficacy and faster onset of action, with longer remission following a single dose, in a head-to-head trial with Procter & Gamble’s commonly used oral bisphosphonate, Actonel (risedronate). The firm adds that although such drugs are well established as the standard of care for Paget’s disease, oral Actonel requires daily administration for two months and patients must avoid eating or drinking for 30 minutes prior to intake. Additional data show that, at six months, 96% of patients taking a single dose of Aclasta showed a therapeutic response, compared to 74% of patients taking 30mg of Actonel, for 60 days. After more than 12 months, the vast majority of patients responding to Aclasta continued to maintain therapeutic response.
Paget’s disease is a chronic skeletal disorder that can cause pain, fractures and deformities, seriously impeding patients’ ability to perform routine activities of daily living. It is the second most common metabolic bone disease after osteoporosis and can lead to serious consequences if not properly treated appropriately.