Friday, February 19, 2010

FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date

THOUSAND OAKS, Calif., Feb 19, 2010 /PRNewswire via COMTEX/—Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company’s Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

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Posted in Press Releases

Tuesday, February 16, 2010

Amgen and Centocor Ortho Biotech Products Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA

THOUSAND OAKS, Calif., Feb 16, 2010 /PRNewswire via COMTEX/—Amgen Inc.  (Nasdaq: AMGN) and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp(R) (darbepoetin alfa), EPOGEN(R) (Epoetin alfa) and PROCRIT(R) (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.

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Posted in Press Releases

Tuesday, February 09, 2010

Denosumab Study Published in The Lancet Oncology Demonstrated 86 Percent Tumor Reduction for Patients with Giant Cell Tumor of the Bone

THOUSAND OAKS, Calif. (February 9, 2010) – Amgen (NASDAQ: AMGN) issued the following statement on the publication of results online today by the Lancet Oncology. For a summary of the manuscript click here.

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Posted in Pipeline News

Monday, February 08, 2010

Denosumab Demonstrated Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Prostate Cancer Patients With Bone Metastases - --Denosumab Trial Met Primary and All Secondary Endpoints by Significantly Delaying Time to First Skeletal Related Event and Significantly Reducing First-and-Subsequent Skeletal Related Events Compared to Zometa -- Second Phase 3 Advanced Cancer Trial to Demonstrate Denosumab Superiority Versus Zometa

THOUSAND OAKS, Calif., Feb 08, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints. Denosumab demonstrated superiority over Zometa for both delaying the time to the first on-study skeletal related event (SRE) (fracture, radiation to bone, surgery to bone or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and reducing the rate of multiple SREs (hazard ratio 0.82, 95 percent CI: 0.71, 0.94). Both results were statistically significant.

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Posted in Press Releases