U.S. FDA Approves Novartis Corporation's Reclast, the First and Only Single-Dose Treatment Regimen for Paget's Disease of the Bone
NEW YORK, April 17 -- The U.S. Food and Drug Administration (FDA) has approved Reclast(R) (zoledronic acid) injection for the treatment of Paget's disease of the bone, the second most prevalent bone disease after osteoporosis. Reclast is the first and only single-dose treatment regimen for Paget's disease and the first new treatment for the disease in nearly a decade.
Until today, standard therapies for Paget's disease -- bisphosphonates taken in pill form -- had to be taken daily for up to six months. Reclast is given as a single 15-minute intravenous infusion by a healthcare professional.
Studies show that Reclast is more effective, offers a longer period of remission and starts working faster than the current standard treatment, Actonel(R) (risedronate sodium). Reclast works by attaching to bone, stopping excessive bone breakdown and rebalancing the body's natural bone remodeling process. The FDA is currently reviewing Reclast as a potential once-yearly treatment for postmenopausal osteoporosis.
For more information about Paget's disease, please contact The Paget Foundation at http://www.paget.org or call 800-23-PAGET (800-237-2438). SATELLITE FEEDS:
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NEWS: Only Single-Dose Treatment For Paget's Disease Receives FDA Approval
FORMAT: B-Roll ADDITIONAL RESOURCES: Video, contact information and more available at http://www.prnewswire.com/broadcast/21208/consumer.shtml SOUNDBITES: -- Charlene Waldman, Executive Director, The Paget Foundation -- Frederick R. Singer, M.D., Director, Endocrine Bone Disease Program, John Wayne Cancer Institute