Novartis: Once-yearly Aclasta approved in EU

Novartis has announced that once-yearly Aclasta (zoledronic acid 5mg) has been approved by the European Commission as a treatment for osteoporosis in men and for the reduciton of new fractures following a broken hip in men and postmenopausal women.

The company said this decision recognises the importance of treating osteoporosis in men, with one in five aged over 50 set to suffer fracture related to the condition.

It added the expansion of the EU label for Aclasta includes data showing a 35 per cent reduction in new breaks in patients treated with the compound who had previously suffered a low-trauma hip fracture.

Novartis said the compound is the only osteoporosis treatment to show a 28 per cent reduction in all-cause mortality in patients following a low-trauma hip fracture.

Steven Boonen, professor of medicine at the Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine in Belgium, said: “Despite the severity and the large numbers affected, osteoporosis in men has received very little attention.”

He added many people view the condition as a woman’s disease, but this is not the case, with it being important for men with osteoporosis to have the same treatment options available to them as women.

In October 2007, Novartis announced Aclasta had been approved for use in Europe as a once-yearly treatment for women with postmenopausal osteoporosis.