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BY OUR PHARMA CORRESPONDENT
8 September, 2005: Zoledronic acid infusion has been found to offer superior efficacy in treating patients with Paget's disease in comparison with another oral pill.
A head-to-head study published in The New England Journal of Medicine (NEJM) showed that a single dose of Aclasta (zoledronic acid 5mg solution for infusion) in patients with Paget's disease offers a longer period of remission and more rapid onset of action compared to the oral bisphosphonate risedronate.
Paget's disease affects 4 million people worldwide. It is the second most prevalent bone disease after osteoporosis and is a chronic, often painful and potentially debilitating bone disorder marked by the malfunction of the body's regular bone-building process. Patients may experience bone pain, skeletal deformity, pathological fractures, secondary arthritis, neurological complications and deafness.
Two identical double-blind, active-controlled trials in patients with Paget's disease compared a single 15-minute IV infusion of Aclasta to oral risedronate (30 mg per day for 60 days) in 357 patients with Paget's disease, from 76 centers in ten countries.
At six months, 96% of Aclasta patients showed a therapeutic response, compared to 74% of patients treated with risedronate (p< 0.001). Aclasta patients also showed a shorter median time to first therapeutic response (64 versus 89 days). Additionally, serum alkaline phosphatase (SAP) levels – a key marker for bone turnover – were normalized in 89% of Aclasta patients, compared with 58% of risedronate patients. The superior response rates with Aclasta were independent of age, gender, baseline SAP levels and previous therapy for Paget's disease, a company release said.
Overall, the number of patients with adverse events were similar in the Aclasta and risedronate groups. The most common adverse events with Aclasta were mild to moderate flu-like symptoms such as muscle aches and low grade fever relating to the infusion, the majority of which occurred within three days of infusion and usually resolved within four days. After three days, adverse events were comparable between the two groups.1
For those patients that responded at the end of six months and entered into the post-trial follow-up for a further six months, there was a loss of therapeutic response in only one out of 113 Aclasta-treated patients, compared with 21 out of 82 risedronate-treated patients.
Based on the results of these studies, Aclasta was licensed for the treatment of Paget's disease in all 25 European Union member states, as well as Norway and Iceland, in April 2005. Canadian regulatory authorities approved Aclasta in June 2005. Aclasta was launched in Germany, the first EU launch market, in May 2005 and is expected to be launched in other European countries during 2005 and 2006. The US Food and Drug Administration issued an "approvable letter" for this product for the treatment of Paget's disease of the bone in March 2005. Novartis is working with the US regulatory agency to gain approval for this indication.
The drug is made and marketed by Novartis AG. Aclasta is the trademark of zoledronic acid 5mg in Europe and the rest of the world. The US tradename is under review.
Aclasta is being studied worldwide in a series of independent, multi-national and multi-center clinical trials program called HORIZON (Health Outcomes and Reduced Incidence with Zoledronic acid ONce Yearly). This clinical development program is the first of its kind to study a single-dose regimen with Aclasta for sustained benefits in the treatment of Paget's disease as well as a once-yearly dosing for osteoporosis. It also includes studies in postmenopausal osteoporosis for prevention of spine and hip fractures, the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis and the treatment of osteogenesis imperfecta in children. Approximately 10,000 patients are enrolled in more than 400 trial centers worldwide. The HORIZON program is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases., the release added.
Headquartered in Basel, Switzerland, Novartis AG is a world leader in pharmaceuticals and consumer health. In 2004, the Novartis group of companies' businesses achieved sales of USD 28.2 billion and a pro forma net income of USD 5.8 billion. The group invested approximately USD 4.2 billion in R&D., Novartis group companies employ approximately 83,700 people and operate in over 140 countries around the world.
BY OUR PHARMA CORRESPONDENT
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