Amgen Inc. (Nasdaq: AMGN) today announced that it will present updated long-term safety and efficacy data for Nplate® (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen will present the first Nplate study in a pediatric setting as well as in patients with myelodysplastic syndromes (MDS) at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (Dec. 5 - 8, 2009).
"We are excited to present data on the safety and efficacy of Nplate in the pediatric setting for the first time," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Similar to adults who have chronic ITP, children living with this disease have limited treatment options. We will also present data from a large global study of Nplate as a treatment for thrombocytopenia in patients with MDS."
SELECTED ABSTRACTS OF INTEREST
Abstracts are available and can be viewed on the ASH website at www.hematology.org. Identified below are selected abstracts of interest on Amgen research. Updated data will be presented at the meeting.
Researchers will present five year follow-up results from the ongoing, open-label extension study on the long-term safety and efficacy of Nplate in adult patients with chronic ITP. Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. These results support previously presented data which illustrated Nplate sustained platelet counts with extended treatment. Additionally, data regarding pediatric treatment of ITP will be presented, as well as results for Nplate in MDS.
- Abstract No. 681 (Embargoed until Dec. 7, 5:00pm): "Long-term Efficacy and Safety of Romiplostim for the Treatment of Patients with Chronic Immune Thrombocytopenia (ITP): 5-year Update from an Open-label Extension Study"
- Abstract No. 680 (Embargoed until Dec. 7, 4:45pm): "A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim in Children With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)"
- Abstract No. 1769 (Embargoed until Dec. 5, 5:30pm): "Efficacy and Safety of Romiplostim in Patients with Low or Intermediate-Risk Myelodysplastic Syndrome (MDS) Receiving Decitabine"
- Abstract No. 1770 (Embargoed until Dec. 5, 5:30pm): "Randomized Phase II Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Patients with Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide"
- Abstract No. 2765 (Embargoed until Dec. 6, 6:00pm): "An Open-Label Extension Study Evaluating the Long-Term Safety and Efficacy of Romiplostim in Thrombocytopenic Patients (Pts) with Myelodysplastic Syndromes (MDS)"
Aranesp® (darbepoetin alfa)
Researchers will also present efficacy and safety data from an independent investigator-led study that is part of the Aranesp Pharmacovigilance program.
- Abstract No. 1701 (Embargoed until Dec. 5, 5:30pm): "Efficacy and Safety of Prophylactic Use of Darbepoetin Alfa in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Treated with Immunochemotherapy: Results of the Interim Analysis of the LNH03-6B GELA Study"