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Novartis' osteoporosis once-yearly bone drug Reclast long-term trial results
  pharmatimes, October 18, 2010
New long-term data for Novartis' once-yearly osteoporosis jab Aclasta/Reclast have cemented its safety and efficacy profile, showing that the drug preserves bone mass and slashes the risk of new spine fractures.
Unveiling its findings over the weekend, the Swiss drug giant said women taking Aclasta (zoledronic acid) for six years cut their risk of new morphometric spine fractures by 52% versus those who stopped treatment at three years, and that in the latter group bone mineral density was seen to dwindle (though remained well above baseline levels), making a strong case for its long-term use.
In addition, the multicenter, double-blind, randomised, placebo-controlled study, which involved more than 1,200 women aged 68 years or older, showed that the number of adverse events between the three- and six-year treatment groups were comparable, and that there was no long-term effect on renal function or increase in risk of osteonecrosis of the jaw or atrial fibrillation.
"These new long-term data reconfirm Aclasta as an important therapeutic option for doctors when considering an osteoporosis medicine for their patients," said Dennis Black, PhD, the study's lead author and Professor of Epidemiology and Biostatistics at the University of California, San Francisco, commenting on the results.
The data certainly lend further weight to the drug's already strong clinical profile. Aclasta is the only-yearly treatment approved in US and Europe to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine and other areas such as the wrist, and is also the only proven therapy to reduce new clinical fracture and all-cause mortality (28% reduction in death) after a recent low trauma hip fracture, Novartis said.
Compliance benefit
Perhaps the drug's most important benefit is its ability to offer year-long efficacy with just a single infusion, compared to rival oral bisphosphonate therapies on the market that are administered daily, weekly or monthly. This provides obvious advantages, particularly in terms of improving treatment compliance - a crucial factor in the effective management of the condition - and could help give the drug a competitive edge over its rivals.
As Novartis points out, numerous studies have found that poor compliance reduces the benefit of therapy and presents a major challenge for health professionals, while others show that around half of patients stop taking osteoporosis therapy within 12 months, primarily because of difficult dosing regimens and side effects, highlighting the need for new therapies that can side-step these difficulties.
Aclasta pulled in sales of $142 million for Novartis in the second quarter of this year, but some analysts are predicting peak sales of $3 billion by 2017 if its reaches its full potential, according to the Wall Street Journal.
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