August 23, 2007 — The FDA has approved Reclast (zoledronic acid) Injection, the first and only once-yearly treatment for postmenopausal osteoporosis.
Approximately 8 million women in the United States suffer from osteoporosis, a disease characterized by low bone mass and reduced bone strength that causes bones to break easily. Osteoporotic fractures are associated with increased morbidity, mortality and healthcare costs.
The approval was based on efficacy and safety data from a three-year study showing that Reclast reduces the frequency of fractures among areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (i.e., hip, wrist, arm, leg, rib). In the trial, Reclast reduced spine fractures by 70 percent and hip fractures by 41 percent.
Reclast belongs to a class of drugs called bisphosphonates, which are used to treat osteoporosis. Research shows that more than half of women on daily or weekly bisphosphonates for postmenopausal osteoporosis will discontinue treatment at the end of one year, potentially leading to a greater risk of fractures. Unlike other bisphosphonate treatments, Reclast is given as a once-yearly 15-minute infusion.
For more information: www.reclast.com