Novartis reports recommendation of once-yearly Aclasta

Novartis has announced that once-yearly Aclasta (zoledronic acid 5mg) has been recommended for use in the European Union (EU) as a treatment for male osteoporosis and in hip fracture patients to reduce the risk of new fractures.

The firm said the former indication is viral as one-in-five men aged over 50 may suffer an osteoporosis-related fracture, with the condition often neglected in male patients.

It said the planned EU label for the compound would include data showing a 35 per cent reduction in new fractures and 28 per cent reduction in all-cause mortality in post-hip fracture patients who have been administered with Aclasta.

Novartis added that this recommendation follows a similar change to the US label for Reclast.

Steven Boonen, professor of medicine at the Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine in Belgium, said: “This positive opinion is an encouraging step forward for the treatment of osteoporosis in both men and women.”

He added that hip fractures can be a potentially life-threatening consequence of osteoporosis, while at present only a few hip fracture patients are treated for osteoporosis.

In April 2008, Novartis announced the publication of new data showing Aclasta is better than risedronate at increasing bone mass in patients whose osteoporosis is caused by glucocorticoids.