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Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Six Years With Similar Safety Profile Observed in Original Fracture Trial
Date:11/5/2011

ed fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025.(5)

About Prolia

Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).

Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is approved in the European Union (EU) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

Prolia is approved in the U.S., Canada, Australia and in all 27 EU member states as well as in Norway, Iceland and Liechtenstein. Applications in the rest of the world are pending.

Prolia is administered as a single subcutaneous injection of 60mg once every six months. For further information on Prolia, including prescribing information and medication guide, please visit www.prolia.com.  

Important U.S. Safety Information

Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may worsen, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D. Patients receiving Prolia should not receive XGEVA® (denosumab), as both Prolia and XGEVA contain the same active ingredient, denosumab.

In the Phase 3 pivotal study, serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious ski
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SOURCE Amgen
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1. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
2. Prolia® (Denosumab) Phase 2 Extension Study Showed Continued Increase in Bone Mineral Density Over Eight Years of Treatment
3. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
4. Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
5. XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
6. Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
7. Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
8. The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
9. XGEVA™ (Denosumab) Significantly Improved Bone Metastasis-Free Survival in Men With Prostate Cancer
10. Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
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