WASHINGTON, DC—The US Food and Drug Administration (FDA) has approved Novartis' Reclast^® (zoledronic acid) injection as the first therapy to prevent postmenopausal osteoporosis for 2 years with a single dose.

Approval was based on a pivotal trial involving more than 500 postmenopausal women with osteopenia and showed that a single infusion of Reclast significantly increased lumbar spine bone mineral density (BMD) by 6.3% at two years compared to placebo in women who were in early menopause and by 5.4% in those in later stages.

"It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis," said Mone Zaidi, MD, PhD, Professor of Medicine, Geriatrics, and Physiology and Director of the Mount Sinai Bone Program at Mount Sinai School of Medicine in New York. "The dosing of Reclast for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years, instead of daily, weekly or monthly."

Reclast was already approved as a once-yearly infusion to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, to treat and prevent osteoporosis caused by glucocorticoids, and for the treatment of Paget's disease.

"We are very pleased that this latest US approval recognizes the large body of safety and efficacy data for Reclast and underlines its potential to protect patients with a number of bone disorders," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Women with low bone mass in the US now have an important new option that is proven to strengthen their bones, and therefore help prevent the onset of osteoporosis, for a full two years with only one infusion."

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year when treating postmenopausal osteoporosis. Reclast contains the same active ingredient found in Zometa^® (zoledronic acid) injection.