Swiss group Novartis received some good news on Friday as European regulators issued a green light for its once-yearly postmenopausal osteoporosis treatment Aclasta.

European approval for Aclasta (zoledronic acid) closely follows its clearance in the USA in August, where it is marketed as Reclast, demonstrating “widespread confidence” in the drug, according to James Shannon, MD, Global Head of Development at Novartis Pharma AG.

The company certainly has high hopes for Aclasta, which is scheduled to undergo its first European launch in the UK this week, as it offers the important benefit of once-yearly dosing compared to rival oral bisphosphonate therapies on the market that are administered daily, weekly or monthly. This provides obvious benefits to the patient as well as potentially improving treatment compliance; Novartis notes that more than 70% of patients prefer a once-yearly infusion of Aclasta to a weekly tablet.

Aside from its patient-friendly dosing, Novartis’ drug is also the only one approved in Europe and the USA to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip and spine, and experts are excited about its potential. “The convenience of a once-yearly dose should improve compliance and bone protection among patients while reducing fracture-related hospitalization and healthcare costs,” commented Steven Boonen, Professor of Medicine at the Centre for Metabolic Bone Diseases & Division of Geriatric Medicine at the Leuven University in Belgium.

Aclasta’s approval was based on data from the three-year Pivotal Fracture Trial involving more than 7,700 women, in which it demonstrated its ability to boost bone strength and cut the risk of spine fractures by 70% and hip fractures by 41%. The reduction in spine fractures was sustained over three years, Novartis said, and bone mineral density increased significantly in the spine by 6.7% and in the hip by 6% compared to patients taking a placebo.

Saving money

A spokeswoman for the company told PharmaTimes that, in the UK, Aclasta will be priced at £283.74 per shot. Although this is more expensive that rival generic therapies on the market, she stressed that, because its unique, once-yearly dosing guarantees treatment compliance, the drug should actually help save on costs related to complications associated with the condition, such as hip fractures, which cost the National Health Service £20,000 each. Consequently, she said the company is confident that Aclasta will be adopted by the UK’s cost-effectiveness body, the National Institute for Health and Clinical Excellence.

Aclasta is now approved in more than 30 countries for the treatment of post-menopausal osteoporosis and in more than 60 countries including the US, Canada and the EU for the treatment of Paget's disease, the second most common metabolic bone disorder. Its clearance in Europe should certainly give sales a boost, and a number of analysts believe it can reach blockbuster status, especially as already over 200 million people across the globe are affected by osteoporosis and the market is expanding substantially.

In women over age 45, the condition accounts for more days spent in hospital than many other diseases, including diabetes, or heart attack and breast cancer, the group said, adding that, in 2000, the total direct costs related to osteoporotic fractures were estimated at 31.7 billion euros, a figure expected to rocket to 76.7 billion euros in 2050, underscoring the need for new weapons against the disease.