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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

Friday, June 6, 2008 General News J E 4
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EAST HANOVER, N.J., June 5 The US Food and DrugAdministration (FDA) has broadened the US indication for once-yearlyReclast(R) (zoledronic acid) Injection to include the prevention of newclinical fractures in patients who have recently had a low-trauma hipfracture(1).

No other osteoporosis treatment has demonstrated a reduction of newclinical 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 isdefined as a composite endpoint of skeletal sites excluding finger, face andtoe.

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

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

Osteoporosis is a condition in which the bones become weak and can breakmore easily(4). Around 10 million people in the US are affected byosteoporosis, which caused an estimated 297,000 hip fractures in the US in2005(4). Of those patients who experience a hip fracture, almost a quarter ofpeople over the age of 50 die from complications within one year(4).

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

The Recurrent Fracture Trial involved more than 2,100 men and women aged50 and older with osteoporosis who had experienced a recent low-trauma hipfracture(3). Results showed that Reclast increased bone mineral density (BMD)and reduced the risk of new clinical fractures by 35% compared to patientstreated with placebo(3). The risk of new spine fractures was reduced by46%(3). The incidence of all-cause mortality was 9.6% in the Reclast group and13.3% in the placebo group(3).

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

Reclast is given as a once-yearly 15-minute intravenous infusion(1). Thismeans 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 ofosteoporosis patients," said Trevor Mundel, MD, Head of Global DevelopmentFunctions at Novartis Pharma AG. "These data support the clear need to treatpatients after hip fracture who are at risk of the potentially devastating andlife-threatening consequences of osteoporosis."

Reclast is already approved in more than 50 countries for the treatment ofpostmenopausal osteoporosis and in more than 70 countries for the treatment ofPaget's disease of bone, the second most common metabolic bone disorder(5).

The active ingredient in Reclast is zoledronic acid 5 mg administered oncea year(1). Zoledronic acid is also available in a different dosage under thebrand
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