FDA APPROVES RECLAST® THE FIRST AND ONLY SINGLE-DOSE TREATMENT REGIMEN FOR PAGET’S DISEASE

Story Summary:

The U.S. Food and Drug Administration (FDA) has approved Reclast® (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^® (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 additional information on Reclast, visit www.reclast.com.

For more information about Paget’s disease, please contact The Paget Foundation at www.paget.org or call 800-23-PAGET (800-237-2438).

Soundbites

• Charlene Waldman, Executive Director, The Paget Foundation
• Frederick R. Singer, M.D., Director, Endocrine Bone Disease Program, John Wayne Cancer Institute
• Joseph R. Tucci, M.D., Director, Division of Endocrinology and Metabolism, Roger Williams Medical Center
• Earl Randall, Person living with Paget’s Disease

B-Roll Includes

**Physician-patient consultation
**Physician examining X-ray
**Patient receiving infusion of Reclast
**Patient lifestyle footage
**Reclast manufacturing

VIDEO PROVIDED BY: "Novartis Pharmaceuticals Corporation"