Novartis Pharmaceuticals Corp (EAST HANOVER, New Jersey) announced that its once-yearly, 15-minute infusion treatment of Reclast® (zoledronic acid) injection has been approved by the US FDA for women with postmenopausal osteoporosis. Zoledronic acid, a bisphosphonate, is currently being considered by the European Commission for the treatment of postmenopausal osteoporosis. European Union approval, under the brand name Aclasta®, is anticipated later in 2007.

The regulatory submissions were based on efficacy and safety data from the 3-year Pivotal Fracture Trial (PFT), showing that Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine, and nonspine (eg, wrist and rib). In this international study involving more than 7700 women between the ages of 65 and 89 with postmenopausal osteoporosis, Reclast reduced the risk of spine fractures by 70% and the risk of hip fractures, which are associated with significant mortality, by 41%. The reduction in spine fractures was sustained over 3 years (60% in year 1, 71% in year 2, and 70% in year 3). The drug significantly reduced the risk of nonspine, all clinical, and clinical spine fractures by 25%, 33%, and 77%, respectively. Bone mineral density increased significantly in the spine by 6.7% and in the hip by 6% in women on Reclast compared with placebo. Reclast is the only treatment proven to reduce fractures across all the common osteoporotic fracture sites, while demonstrating a favorable safety profile.

The PFT found over all incidence of adverse events experienced with the drug was comparable with placebo. Analysis of key safety parameters, including kidney and bone safety, found the drug to be comparable with placebo. No spontaneous reports of osteonecrosis of the jaw (ONJ), a rare occurrence in the osteoporosis population treated with bisphosphonates, were seen in the study. An increased number of cases of serious atrial fibrillation were observed in women on Reclast compared with those on placebo (1.3% vs 0.4%). These findings have not been observed in other clinical studies or in postmarketing experience from over 1.5 million patients treated with zoledronic acid for oncology indications.

Reclast/Aclasta is approved in more than 60 countries including both the US and EU, plus Canada for the treatment of Paget's disease, the second most common metabolic bone disorder. Data from a large trial in men and women following hip fracture, as well as studies for treating corticosteroid-induced osteoporosis and male osteoporosis will provide additional efficacy and safety data for Reclast. These results will be available in the second half of 2007.

The active ingredient in Reclast is also available in a different dosage under the brand name Zometa® (zoledronic acid 4 mg) injection for use in certain oncology indications.

—A. Techman