The CHMP recommendation was based on an extensive review of data from clinical studies in osteoporosis, including data from the 7700-woman pivotal fracture trial, which demonstrated a 70% reduction in spine fractures and a 41% reduction in hip fractures in women using Aclasta compared with women on placebo.
Reclast was launched in April 2007 in the US after regulatory approval as the first new treatment in nearly a decade for patients with Paget's disease of the bone. Aclasta/Reclast is already approved in more than 50 countries, including the EU and Canada, for use in patients with Paget's disease. Zoledronic acid, the active ingredient of Aclasta/Reclast, is also available under the brand name Zometa® for use in oncology indications.
Aclasta/Reclast was found to be generally safe and well tolerated in clinical trials. In the pivotal fracture trial, an increased number of cases of serious atrial fibrillation were observed in women given Aclasta compared with those on placebo (1.3% vs 0.5% respectively). However, this finding has not been observed in other clinical studies or in postmarketing experience with over 1.5 million patients treated with zoledronic acid for oncology indications. No spontaneous reports of osteonecrosis of the jaw (ONJ), a rare occurrence in the osteoporosis population treated with bisphosphonates, were seen in the pivotal fracture trial.
In the second half of 2007, data from a large trial in men and women with osteoporosis following hip fracture will provide additional efficacy and safety data for Aclasta.
—A. Techman