Novartis Pharmaceuticals AG (BASEL, Switzerland) announced that the European Commission has approved once-yearly Aclasta^® (zoledronic acid 5 mg) for the treatment of osteoporosis in men who are at increased risk of fractures, and has broadened the drug’s label to include reduction of new fractures in men and postmenopausal women with osteoporosis who have recently suffered a hip fracture. In June 2008, the US FDA broadened the label for such indications.

The commission’s approval, following a positive opinion issued in July 2008 by the Committee for Medicinal Products for Human Use, will apply in all 27 EU member states, Iceland, and Norway. Approval was based on pivotal data from the Recurrent Fracture Trial, involving >2100 adults aged ≥50 who had recently suffered a low-trauma hip fracture. It is the only osteoporosis treatment to demonstrate these benefits in such patients and to reduce the risk of fractures at all key sites, including the hip, spine, and nonspine (eg, wrist and rib). Aclasta was shown to reduce the risk of new clinical fractures by 35% compared with patients receiving placebo, and to increase bone mineral density (BMD). The risk of new spine fractures was reduced by 46%. The new label also includes data from the same study showing that all-cause mortality was reduced by 28% in the Aclasta-treated group compared with those receiving placebo (101 vs 141 deaths, respectively).

A 2-year head-to-head trial comparing the therapy with weekly oral alendronate provided additional data on the treatment of male osteoporosis. The study comprised >300 osteoporotic men and demonstrated that the drug preserved and improved lumbar spine BMD at 24 months.

More than a quarter of a million patients have been treated with Aclasta, and the new approvals allow two new populations to be treated with the regimen, which is administered by once-yearly 15-minute infusion. The therapy was approved in the EU in October 2007 for the treatment of osteoporosis in postmenopausal women and is now approved in an additional >80 countries. Aclasta, available in the US under the trade name Reclast^®, is also approved in >80 countries for the treatment of Paget's disease, the second most common metabolic bone disorder. Zoledronic acid, the active ingredient of Aclasta, is also available under the trade-name Zometa^® for use in oncology indications.

Aclasta has a demonstrated tolerability profile. The most common adverse events were transient postdose symptoms, such as fever and muscle pain, which can be reduced with the administration of paracetamol or ibuprofen shortly after drug infusion. Symptoms occurred within the first 3 days following Aclasta administration and resolved within 3 days.