Released 01 October 2008

New osteoporosis drug approved in Europe

The European Commission (EC) has approved once-yearly Aclasta for the treatment of osteoporosis in men who are at increased risk of fractures.

EC approval was based on a clinical trial of 2,100 patients that revealed the drug reduces the risk of new clinical fractures by 35 per cent in both men and postmenopausal women with osteoporosis who have recently suffered a hip fracture. Aclasta was approved by the EC for osteoporosis in post-menopausal women a year ago.

The drug, manufactured by Novartis, was also shown to reduce the risk of new spinal fracture by 46 per cent.

Dr Trevor Mundel, global head of development functions at Novartis, commented: "More than a quarter of a million patients have already been treated with Aclasta, and these new approvals mean that two new populations can be treated with this once-yearly dosing regimen.

"This once-yearly dosing represents a convenient way to help protect both men and women against the life-threatening consequences of osteoporosis."

A spokesman for the Arthritis Research Campaign said that it was not widely recognised that men as well as women could be affected by osteoporosis.
ADNFCR-1096-ID-18806119-ADNFCR

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