Novartis once-a-year drug Aclasta aids bones

A dose of the Novartis drug Aclasta (zoledronic acid) halted bone deterioration and abnormal bone growth for at least a year in about 95% of patients with Paget's disease, according to a new international study.

The study, published in The New England Journal of Medicine , suggests the dug is more effective than other currently available oral drugs.

'This study provides for a new and effective option for patients with Paget's disease by demonstrating that a single dose of Aclasta is more effective than the current standard of care - both in time to first response and in normalising the bone turnover process for longer periods,' said lead study author Ian Reid, md, University of Auckland, New Zealand.

Affecting four million people worldwide, Paget's disease is the second most prevalent bone disease after osteoporosis and is a chronic, often painful bone disorder that can lead to fractures, secondary arthritis, neurological complications and deafness.

Aclasta was launched in Germany in May 2005 and is expected to be launched in other European countries during 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 being studied worldwide in a series of independent, multinational and multi-center clinical trials under a programme called HORIZON (Health Outcomes and Reduced Incidence with Zoledronic acid ONce yearly). This includes studies in osteoporosis for prevention of spine and hip fractures.