Once-yearly Aclasta (zoledronic acid 5 mg) has been approved in the European Union to treat men and postmenopausal women with osteoporosis caused by long-term use of glucocorticoids (steroids).
Glucocorticoids are widely used to treat inflammatory conditions such as asthma and rheumatoid arthritis, but also cause bone loss and can increase the risk of fracture in up to 50% of patients on long-term glucocorticoid therapy.
This approval in glucocorticoid-induced osteoporosis (GIO) represents a fifth indication for Aclasta, which is already approved to treat osteoporosis in men and postmenopausal women, including those who have experienced a low-trauma hip fracture.
The new indication is based on study data published in the Lancet, which showed that Aclasta, given once a year as a 15-minute infusion, is more effective at treating bone loss than daily oral risedronate, a currently established therapy.
"Oral bisphosphonates have been used for many years for the treatment of GIO, but they are associated with poor compliance as patients frequently fail to take them as prescribed," said Professor David Reid, Head of the Division of Applied Medicine at the University of Aberdeen. "Available data show that patients who remember to take their medicines only half of the time receive little or no protection."
He added: "The approval of Aclasta is a significant step forward, as it is more effective and faster-acting than a current established therapy for the treatment of GIO and has the advantage of year-long compliance and sustained osteoprotection."
Aclasta is the only bisphosphonate approved in the EU and US to reduce the risk of fractures at all key osteoporotic fracture sites. It is also approved to treat Paget’s disease of the bone.
"This European approval marks another important achievement for Aclasta by adding to the broad spectrum of patients who can now be treated with this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Since its launch in 2007, Aclasta has been used in more than 500,000 patients, demonstrating that an annual infusion has become a valuable treatment option."