Trial shows long-term benefits of Novartis’ Aclasta
pharmafile | October 18, 2010 | News story | Research and Development, Sales and Marketing | Novartis, aclasta, osteoporosis
Novartis has published new data at the annual meeting of the American Society for Bone and Mineral Research in Toronto that show the long-term efficacy of its osteoporosis drug Aclasta.
A six-year study of the once-yearly infusion postmenopausal osteoporosis drug showed it reduced the risk of new spine fractures by 52% over six years, versus patients who stopped treatment after three years.
Dennis Black, the study’s lead author and Professor of Epidemiology and Biostatistics at the University of California, said: “These new findings show that continued treatment with zoledronic acid for six years continues to maintain bone mass and reduces vertebral fractures risk with no change to its favourable safety profile compared to discontinuation of treatment after three years.”
This builds upon existing data from previous clinical studies and confirms that Aclasta helps preserve bone turnover, the balanced process by which the bone is constantly renewed and re-modelled throughout adult life.
Trevor Mundel, global head of development at Novartis, said: “Aclasta is highly effective at protecting patients against osteoporotic fractures for a long period of time and its once-yearly dosing represents an important improvement for patients and doctors in terms of compliance for an entire year.”
This long-term study, which extended the HORIZON Pivotal Fracture Trial by three years, is a multi-centre, double-blind, randomised, placebo-controlled study to evaluate the long-term efficacy and safety of Aclasta in the treatment of postmenopausal osteoporosis.
The extension study evaluated more than 1,200 women aged 68 years or older: after three years of therapy, participants were randomised to either receive an Aclasta infusion or an annual placebo infusion for additional three years.
The primary endpoint of the study was the percentage change in the bone mineral density (BMD) at the femoral neck at year six versus year three.
Secondary endpoints included evaluation of BMD at other sites, fractures, changes in bone turnover markers and overall safety.
Aclasta is already approved in more than 90 countries and for up to six indications to treat a number of patients, from the newly diagnosed to those with more severe forms of osteoporosis.
Current osteoporosis treatments
The most recently approved treatment for postmenopausal osteoporosis is Amgen’s Prolia (denosumab), which received the thumbs up from the EMA in June.
Prolia is a new class of monoclonal antibodies given via injection twice a year and is expected to make $5 billion per year by 2015.
One of the biggest-selling treatments on the market at the moment is Roche/GlaxoSmithKline’s once-monthly oral treatment Boniva that was approved in 2005.
The previous blockbuster osteoporosis drug was Merck’s Fosamax, an oral bisphosphonate compound that lost its patent in 2009. It came under heavy criticism after some patients claimed it caused them osteonecrosis (loss of blood supply in the bone) of the jaw.
This disease affects an estimated 75 million people in Europe, the US and Japan, and one in three women over the age of 50 – as well as one in five men – will suffer an osteoporotic fracture in their lifetime.
Ben Adams
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