The drug is administered once a year via a 15-minute infusion. Current osteoporosis treatments are taken daily, weekly or monthly by pill, nasal spray, skin patch or injection.
Osteoporotic women, especially over the age of 50, are more prone to suffer from fracture in their lifetime. The disease is responsible for 1.5 million fractures every year.
It is estimated that approximately 20 percent of women 50 years and older who suffer a hip fracture will die within one year.
Osteoporosis is the silent disease that makes bones prone to fracture and is a major public health threat for more than 28 million Americans.
The disease, which typically strikes women after they reach menopause, reduces the bone mineral density (BMD) of the women's bones, thus disrupting its bone microarchitecture. It also alters the amount and variety of non-collagenous proteins in bone making them more prone to fracture.
The studies by the manufacturer has shown that Reclast reduced the risk of spine fractures by 70 percent in more than 7,700 women as compared to the conventional oral drugs that just half them.
According to a press release by Novartis, since Reclast is a once-a-year-treatment, it can prove beneficial for many women who tend to neglect their health and do not receive proper treatment for it.
Reclast is already sold in the U.S. for treating a bone disorder called Paget's disease and is one of a class of osteoporosis drugs called bisphosphonates. Novartis predicts its annual worldwide sales could reach $930 million by 2011 by the new FDA approval.
