European Commission Approves Zoledronic acid for the Treatment of Paget's Disease of Bone
Apr 24, 2005 - 8:12:38 AM
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
"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. "Aclasta offers real benefits over oral bisphosphonates in the treatment of Paget's disease and resolves the issue of compliance."
"If you suffer from Paget's disease, you can't enjoy everyday activities such as tennis, walking or digging in the garden," added Dr. David Birch, who has been suffering from Paget's disease for 33 years. "The oral therapies currently available are associated with a lot of constraints."
In pivotal clinical studies, at six months, 96 percent of patients taking a single dose of Aclasta showed a therapeutic response, compared to 74 percent of patients taking 30 mg of risedronate, for 60 days.1 After more than 12 months, the vast majority of patients responding to Aclasta continued to maintain therapeutic response.3 At six months, serum alkaline phosphatase (SAP) levels - a key marker for bone turnover - were normal in 89 percent of Aclasta patients, compared with 58 percent of risedronate patients.1
Paget's disease, the second most common metabolic bone disease after osteoporosis6, 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.7 This is a disease that can be difficult to diagnose, as not all patients experience noticeable symptoms7, leaving many untreated.
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