Novartis’ bisphosphonate infusion, Aclasta®, received approval in the EU for the treatment of men and postmenopausal women with osteoporosis caused by long-term glucocorticoid therapy. The drug is already marketed in the U.S. for this indication under the name Reclast.
The EU approval is the fifth for the drug, which is marketed in Europe and the U.S. as a once-yearly treatment for osteoporosis in men and postmenopausal women as well as for treating Paget’s disease. In May 2009 the FDA also approved the administration of Reclast just once every two years for postmenopausal osteoporosis therapy.
Novartis says the new glucocorticoid-induced osteoporosis (GIO) approval for Aclasta in the EU was based on trial data showing that administration of the drug once a year as a 15-minute infusion was more effective at treating bone loss than daily oral Actonel (Procter & Gamble Pharmaceuticals/ sanofi-aventis) . It also reportedly generated greater increases in bone mineral density after six months.
Use of oral bisphosphonates for treating GIO is associated with poor compliance, according to David M. Reid, a Novartis clinical trial investigator and head of the division of applied medicine at the University of Aberdeen. Moreover, patients who only remember to take them half the time actually gain little or no protection, he adds. “The approval of Aclasta is a significant step forward, as it is more effective and faster-acting than the current established therapy for the treatment of GIO and has the advantage of year-long compliance and sustained osteoprotection.”
Aclasta/Reclast achieved worldwide sales of $254 million in 2008. The drug’s API, zoledronic acid, is also approved as Zometa® for treating cancer patients with bone metastases. Zometa came third in Novartis’ top-20 pharmaceutical sales list for 2008, with worldwide sales netting the company $1.38 billion (up 3% in local currencies) and $666 million (also up 3%) in the U.S. alone.
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