June 5, 2008 - The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast® (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture1.
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). 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.
The details can be read here.
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