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FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
Date:6/5/2008

- Revised label includes data showing 35% reduction in new clinical

fractures in patients treated with Reclast following a recent hip

fracture(1) - Few patients currently receive osteoporosis treatment following hip

fracture despite high risk of morbidity and mortality(2) - Safety and efficacy profile of Reclast, already approved for treatment of

postmenopausal osteoporosis(1), reinforced in revised label

EAST HANOVER, N.J., June 5 /PRNewswire/ -- The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast(R) (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture(1).

No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g., due to a fall from standing height or less)(1). A clinical fracture is defined as a composite endpoint of skeletal sites excluding finger, face and toe.

The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast(3).

"The consequences of osteoporosis can be devastating, particularly hip fractures. However, few patients actually receive treatment for the prevention of additional fractures after a hip fracture(2)," said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. "In the first large scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture."

Osteoporosis is a condition in which the bones become weak and can break more easily(4). Around 10 million people in the US are
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SOURCE Novartis
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