FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hi...(affected byosteoporosis which caused an ...),Health

Among those who experience a hip fracture, 85% need help walking at six months, nearly 20% who could walk before their hip fracture require long-term nursing care, and all remain at high risk of further fracture(4). Yet, currently few patients are treated for osteoporosis following a hip fracture(2).

The Recurrent Fracture Trial involved more than 2,100 men and women aged 50 and older with osteoporosis who had experienced a recent low-trauma hip fracture(3). Results showed that Reclast increased bone mineral density (BMD) and reduced the risk of new clinical fractures by 35% compared to patients treated with placebo(3). The risk of new spine fractures was reduced by 46%(3). The incidence of all-cause mortality was 9.6% in the Reclast group and 13.3% in the placebo group(3).

The updated US label further reinforces the safety and efficacy of Reclast, the only once-yearly treatment for postmenopausal osteoporosis approved in the US and European Union (EU) (under the name Aclasta(R)) for the reduction in the incidence of fractures in all key areas of the body typically affected by this disease, including the hip, spine and non-spine(1). Regulatory approval is also being sought for Aclasta in the EU for this broadened indication.

Reclast is given as a once-yearly 15-minute intravenous infusion(1). This means a single treatment, along with daily calcium and vitamin D supplements, helps protect against fracture for a full year.

"The new label reinforces the potential of Reclast for treating a range of osteoporosis patients," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "These data support the clear need to treat patients after hip fracture who are at risk of the potentia
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