EAST HANOVER, N.J. The Food and Drug Administration has approved Reclast (zoledronic acid) injection for the prevention of postmenopausal osteoporosis for two years with a single dose, Novartis Pharmaceuticals announced Monday.
Reclast already is approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis. Reclast also is approved for the treatment of Paget's disease of bone, the second most common metabolic bone disorder, in men and women.
“We are very pleased that this latest U.S. 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,” stated Trevor Mundel, global head of development at Novartis Pharma. “Women with low bone mass in the U.S. 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.”
“It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis,” stated Mone Zaidi, professor of medicine, geriatrics and physiology at Mount Sinai School of Medicine. “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.”
The FDA decision is based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass, showing that a single infusion of Reclast significantly increased bone mineral density (BMD) at two years compared to placebo.
Approximately 22 million women in the U.S. have osteopenia, putting them at increased risk of osteoporosis, a disease that causes bones to break more easily. Osteoporosis is a major public health issue affecting an estimated 10 million men and women.