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Aclasta recommended for EU approval

The Committee for Medicinal Products for Human Use, the review arm of the European Medicines Agency, has recommended Novartis' Aclasta
The Committee for Medicinal Products for Human Use (CHMP), the review arm of the European Medicines Agency (EMEA), has recommended Novartis' Aclasta.

The recommendation was based on clinical data from a recent study involving more than 2,100 men and women over the age of 50 who had experienced a low-trauma hip fracture. Results showed the drug reduced the risk of new clinical fractures by 35 per cent, compared to patients treated with a placebo, and cut the risk of new spine fractures by 46 per cent.

Aclasta is already approved for use in the US under the brand name Reclast. Recently, the US Food and Drug Administration (FDA) broadened the medicines label to include data about its ability to reduce the risk of new clinical fractures in patients who have already sustained a low-trauma hip fracture.

A final decision on drug approval from the European Commission is expected to be delivered within three months, at which point the drug could be approved for use in all 27 EU countries.

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

Approximately 1.6 million hip fractures were reported globally in 2000 and the number of hip fractures in the EU is estimated at 179,000 for men and 611,000 for women. The current healthcare bill for treatment osteoporotic fractures is 31.5bn.

Aclasta, which is administered by once-yearly infusion, was approved in the EU in October 2007 for the treatment of osteoporosis in postmenopausal women. Aclasta is the only treatment for postmenopausal osteoporosis approved in the EU and US to reduce the risk of fractures at all key sites, including the hip, spine and non-spine areas, such as the wrists and ribs. It is now approved in more than 70 countries, and in more than 80 countries for the treatment of Pagetís disease of bone, the second most common metabolic bone disorder.

Aclasta has a demonstrated tolerability profile. The most common adverse events associated with Aclasta were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first three days following Aclasta administration and resolved within three days. The incidence of post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly after Aclasta infusion.

25th July 2008


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