Friday, December 14, 2007
Pivotal Phase 3 Data Show Denosumab Increased Bone Density Throughout Skeleton in Non-Metastatic Breast Cancer Patients on Adjuvant Aromatase Inhibitor Therapy
A Study Evaluating Twice Yearly Dosing with Denosumab Met All Primary and Secondary Endpoints
SAN ANTONIO – Dec. 14, 2007 – Amgen (NASDAQ:AMGN) today announced results of the first Phase 3 pivotal study to complete in the denosumab oncology development program. The study evaluated denosumab’s effect on bone density across the skeleton in women with non-metastatic breast cancer who were receiving adjuvant Aromatase Inhibitor (AI) Therapy. These results were presented during the Late Breaking Session at this year’s 30th Annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.
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Monday, December 10, 2007
Pivotal Phase 3 Nplate(TM) Study in Non-Splenectomized Patients Met Primary Endpoints
Data Also Shows Potential of Nplate as a Long-term Treatment Option for Chronic Adult Immune Thrombocytopenia Purpura
ATLANTA – Dec. 10, 2007 – Amgen Inc. (NASDAQ:AMGN) today announced results from a second randomized, pivotal Phase 3 study where Nplate(TM) (romiplostim) increased and sustained platelet counts in non-splenectomized (spleen not removed) adult patients with chronic Immune Thrombocytopenic Purpura (ITP). Additionally, Nplate-treated patients taking concurrent ITP medications such as corticosteroids were able to reduce or discontinue these medications. Adult ITP is a chronic and serious autoimmune disorder characterized by low platelet counts in the blood, a condition known as thrombocytopenia. These Phase 3 data were presented today in an oral session at the 49th American Society of Hematology Annual Meeting (ASH) in Atlanta, Georgia (Abstract #565).
Read the rest of this entryPosted in Press Releases
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