Once-yearly Aclasta (zoledronic acid 5 mg) has passed another important milestone with a recommendation for European Union approval to treat osteoporosis in men who are at increased risk of fractures.

Osteoporosis is an important health concern for men, with an estimated one out of five over the age of 50 experiencing an osteoporotic fracture. In addition, the Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the label to include data showing that Aclasta reduced the risk of new clinical fractures by 35 per cent in men and postmenopausal women who have recently had a low-trauma hip fracture (e.g. due to a fall from standing height or less).

Aclasta is the only osteoporosis treatment to demonstrate this benefit. The revised label also includes data showing that in this patient population, all-cause mortality was reduced by 28 per cent in the Aclasta-treated group compared to patients receiving placebo or dummy drug. The positive opinion was issued by the CHMP, which reviews medicines for the European Commission (EC). The EC generally follows the CHMP's recommendations and delivers its final decision within three months. The decision will apply in all 27 EU member states plus Iceland and Norway.

The CHMP recommendation comes shortly after the Food and Drug Administration (FDA) broadened the US label to include data showing the reduced risk of new clinical fractures in patients who have recently had a low-trauma hip fracture. Aclasta is available in the US under the trade-name Reclast.

The European positive opinion is based on pivotal data from the landmark Recurrent Fracture Trial, involving more than 2,100 men and women aged 50 and older who had experienced a recent low-trauma hip fracture. Results showed that Aclasta reduced the risk of new clinical fractures by 35% compared to patients treated with placebo, and increased bone mineral density (BMD) at total hip and femoral neck. The risk of new spine fractures was reduced by 46%.

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 (e.g. wrist and rib). It is now approved in more than 70 countries, and in more than 80 countries for the treatment of Paget's 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. Zoledronic acid, the active ingredient of Aclasta, is also available under the trade-name Zometa for use in oncology indications.