Amgen Cites Osteoporosis Injectable’s Efficacy Over Fosamax In Study
This article was originally published in The Pink Sheet Daily
Executive Summary
Company presents preliminary Phase II results for AMG 162 that show a significantly greater total hip bone mineral density compared to Merck’s Fosamax; changes in lower spine BMD were comparable between the two agents. Amgen has initiated registration for a Phase III study.
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Amgen Osteoporosis Drug Submission Pushed To 2008 To Await Three-Year Data
Submission for Amgen's RANK ligand antibody AMG 162 must wait until 2008 at the earliest, the firm says; FDA guidance calls for three-year data. Pivotal studies are ongoing for four indications, including postmenopausal osteoporosis and reduction in bone marrow density in breast and prostate cancer patients.
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