Aclasta (zoledronic acid 5 mg) has received European Union approval as the first once-yearly treatment for women with postmenopausal osteoporosis.
The announcement closely follows the recent approval in the US, where the Food and Drug Administration (FDA) approved Aclasta under the brand name Reclast in August 2007. The European Commission decision applies to all 27 member states, Norway and Iceland.
"We are very pleased to receive EU approval, especially as it comes so soon after a similar decision in the US," said James Shannon, MD, global head of development at Novartis Pharma AG. "This demonstrates widespread confidence in Aclasta, which provides physicians and patients with a completely new way to manage osteoporosis. The unique once-yearly dosing of this medicine has the potential for significant compliance benefits and improved quality of life for women with osteoporosis".
Unlike oral bisphosphonate therapies taken daily, weekly or monthly, Aclasta is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment, a patient can receive a full year's protection against the effects of osteoporosis. Data show that more than 70 per cent of patients prefer a once-yearly infusion of Aclasta to a weekly tablet.
Osteoporosis is a long-term bone disease that causes bones to break more easily. The need for more effective treatments is based on estimates that about 200 million people worldwide suffer from this disease and that one of two women over age 50 will suffer an osteoporotic fracture in their lifetime.
Aclasta is the only treatment approved in the EU and US to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (e.g. wrist and rib).
"Aclasta is highly effective at reducing fractures and can be given once-yearly which is a significant benefit to patients and clinicians," said Steven Boonen, Professor of Medicine at the Centre for Metabolic Bone Diseases and division of geriatric medicine at the Leuven University in Belgium. "The convenience of a once-yearly dose should improve compliance and bone protection among patients while reducing fracture-related hospitalization and healthcare costs".
Results of the first-ever clinical study in patients with osteoporosis who had suffered a hip fracture, published in September in the The New England Journal of Medicine, show a once-yearly infusion of Aclasta reduced the risk of any type of subsequent osteoporotic fracture by 35 per cent compared to patients treated with placebo. The recurrent fracture trial involving more than 2,100 men and women also found the risk of death was significantly reduced by 28 per cent in the Aclasta patient group compared to the placebo group.
The regulatory approvals were based on efficacy and safety data from another study, the three-year Pivotal Fracture Trial involving more than 7,700 women. In this study, Aclasta was shown to increase bone strength and reduce the risk of spine fractures by 70 per cent and hip fractures by 41 per cent. The reduction in spine fractures was sustained over three years, and bone mineral density increased significantly in the spine by 6.7 per cent and in the hip by 6 per cent in women on Aclasta compared to placebo.
Osteoporotic fracture risk is often under-diagnosed and under-treated, resulting in sub-optimal outcomes and costs to healthcare systems. Fractures can lead to reduced quality of life and loss of independence; someone with osteoporosis may also become partially disabled or immobilized, thereby requiring long-term care.
The active ingredient in Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa (zoledronic acid 4 mg) Injection for use in certain oncology indications.