Tuesday, August 25, 2009

Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type 2 Diabetes

No Statistically Significant Difference in Cardiovascular and Renal Composite Endpoints Between Aranesp and Placebo

THOUSAND OAKS, Calif.—Aug. 25—Amgen (Nasdaq: AMGN) today announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type 2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp((R)) Therapy, or TREAT), treatment of anemia with Aranesp(R) (darbepoetin alfa) to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment.

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Monday, August 17, 2009

Vectibix(R) Significantly Improved Progression-Free Survival in Second-Line Treatment of KRAS Wild-Type Metastatic Colorectal Cancer

Second Prospective Phase 3 Vectibix Combination Chemotherapy Trial to Show Progression-Free Survival Advantage in KRAS Wild-Type Population

THOUSAND OAKS, Calif. – Aug. 17 – Amgen (Nasdaq: AMGN) today announced positive top-line results from a Phase 3 trial evaluating Vectibix (panitumumab) in combination with FOLFIRI (an irinotecan-based chemotherapy) as a second-line treatment in 1,186 patients with metastatic colorectal cancer (mCRC). The co-primary endpoints, tested independently, were progression-free and overall survival.

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Thursday, August 13, 2009

Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting

THOUSAND OAKS, Calif. – Aug 13, 2009 – Amgen Inc. (Nasdaq: AMGN) issued the following statement on the outcome of today’s meeting with the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) to review the potential use of Prolia(TM) (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer.

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Thursday, August 13, 2009

Amgen to Discuss Denosumab Data at Today's Advisory Committee for Reproductive Health Drugs

 Committee to Review Denosumab in Women with Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation Therapy for Either Prostate or Breast Cancer

THOUSAND OAKS, Calif. – Aug 13, 2009 – Amgen Inc. (Nasdaq: AMGN) today will summarize data from the submitted Biologic License Applications (BLAs) for denosumab for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in breast and prostate cancer patients undergoing hormone ablation at a meeting with the U.S. Food and Drug Administration’s (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD).

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Tuesday, August 11, 2009

Studies Published in the New England Journal of Medicine Highlight Potential New Option in the Treatment of Bone Loss

Twice-Yearly Administration of Denosumab Resulted in 68 Percent Reduction in Risk for a Vertebral Fracture and 40 Percent Reduction in Risk for a Hip Fracture in Women with Postmenopausal Osteoporosis

Denosumab Administered Twice-Yearly Reduced the Incidence of New Vertebral Fractures by 62 Percent in Men with Non-Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy

 

 

THOUSAND OAKS, Calif. – Aug. 11 /PRNewswire-FirstCall – Amgen Inc. (Nasdaq: AMGN) today announced the publication of results from two pivotal Phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss. In both studies, published today in The New England Journal of Medicine (NEJM), patients receiving twice-yearly denosumab experienced significant increases in bone mineral density (BMD) compared to placebo, associated with more than 60 percent reduction in vertebral fracture in both patient populations.(1,2) These data were previously reported by Amgen at medical congresses.

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