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April 18, 2007

Novartis’ Drug for Second Most Prevalent Bone Disease Approved

  • Novartis reports that the first new treatment for Paget’s disease in nearly a decade has been approved. The company’s Reclast is also the only single-dose infusion therapy. Currently, oral treatments are taken daily for up to six months.

    “The fact that Reclast is both highly effective and can last for several years in most patients could make this the new standard of care for Paget’s patients,” remarks Frederick R. Singer, M.D., Novartis consultant and director of the endocrine/bone disease program at John Wayne Cancer Institute, Santa Monica, CA. “Current bisphosphonate therapy, while generally effective, does not induce similar long-term remissions.”

    Clinical studies show that Reclast is more effective, starts working faster, and offers a longer period of remission than Actonel (risedronate sodium), the current standard treatment for patients with Paget’s disease, according to Novartis. Reclast is administered as a single 5-mg, 15-minute intravenous infusion by a healthcare professional.

    Additionally, Reclast is under review for approval as a once-yearly treatment for women with postmenopausal osteoporosis. James Shannon, M.D., head of development at Novartis Pharma, adds that, “We are exploring the full clinical potential of this agent in treating other metabolic bone diseases, including postmenopausal osteoporosis.”