Friday, December 19, 2008

Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer

THOUSAND OAKS, Calif. – Dec. 19 – Amgen Inc. (Nasdaq: AMGN), today announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six Phase 3 trials involving more than 11,000 patients.

Posted in Press Releases, Pipeline News

Tuesday, December 16, 2008

Oncology Biomarker KRAS to be Discussed at FDA Panel Meeting

THOUSAND OAKS, Calif. – Dec 16 – KRAS Biomarker Presents Potential to Personalize Colorectal Cancer Treatment Determining Who Can Benefit from Vectibix(R)

Amgen today announced they will discuss the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-epidermal growth factor receptor (EGFr) antibody Vectibix(R) (panitumumab) with the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC).

Posted in Press Releases

Monday, December 08, 2008

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

Interim Phase 2 MDS Data Also Presented at ASH Annual Meeting

SAN FRANCISCO – Dec 08 – Amgen Inc. today released updated results from the ongoing, open-label extension study of the long-term safety and efficacy of Nplate(TM) (romiplostim) in adult patients with chronic immune thrombocytopenic purpura (ITP). Chronic ITP is a chronic and serious autoimmune disorder characterized by lower than expected platelet counts in the blood, sometimes leading to serious bleeding events. The results were presented today as an oral presentation at the 50th Annual Meeting of the American Society of Hematology (ASH Abstract # 402). Results from a study of Nplate in myelodysplastic syndromes (MDS) also were presented.

Posted in Press Releases, Product News