Amgen (Nasdaq: AMGN) today announced that it will present data from several key Nplate® (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla. Results from six studies evaluating Nplate in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) add to the growing body of data supporting the use of Nplate in this setting, including the final efficacy and safety results from the largest and longest study of Nplate in adult chronic ITP. Amgen will also present data for other marketed products including Neulasta® (pegfilgrastim) and Aranesp® (darbepoetin alfa).
"The complete results from a 5-year open-label extension study of Nplate in the adult chronic ITP setting show that Nplate increases and sustains platelet counts in these patients and that adverse event rates were consistent with those reported in previous studies," said Sean Harper, M.D., senior vice president, Global Development and Chief Medical Officer at Amgen. "This is the largest and longest study of Nplate in this setting, and reinforces the potential of Nplate as a long-term treatment option."
Amgen also announced the expansion of its Neulasta FIRST STEP® Program to its newly established co-pay coupon umbrella program, the Amgen FIRST STEP™ Program for commercially insured patients. The Amgen FIRST STEP™ Program will feature the Nplate FIRST STEP™ Program and Neulasta FIRST STEP® Programs. The Amgen FIRST STEP™ Program is significant among oncology commercial co-pay coupon programs, as it is the first program under the medical benefit with no income eligibility requirement. The program is intended to help eligible patients meet their deductible, co-insurance, and/or co-payment requirements under the medical benefit for Neulasta and Nplate. Under this program, eligible patients will incur no out of pocket costs for their first Nplate or Neulasta treatment associated with a new treatment regimen and will pay a maximum of $25 for subsequent injections. More information, eligibility requirements, restrictions and limitations about the co-pay coupon program are available at AmgenFIRSTSTEP.com.
SELECTED ABSTRACTS OF INTEREST INCLUDE:
Abstracts are available on the ASH website at http://www.hematology.org and updated data will be presented at the meeting.
Nplate ITP Data
- Long-Term Efficacy and Safety of Romiplostim Treatment of Adult Patients with Chronic Immune Thrombocytopenia (ITP): Final Report from an Open-Label Extension Study
(Abstract No. 68; Oral Presentation; Sunday, Dec. 5, 4:45 p.m. EST, room 230)
- The Effects of Romiplostim or Standard of Care (SOC) on Splenectomy and Treatment Failure of Patients Who Had Immune Thrombocytopenia (ITP) for Less Than or Equal to One Year
(Abstract No. 3702; Poster III-481; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall A3/A4)
- Analysis of Mortality Rates During Romiplostim Clinical Studies of Patients (Pts) with Immune Thrombocytopenia (ITP)
Abstract No. 3701; Poster III-480; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall A3/A4)
- Patient Quality of Life (QoL) in Nonsplenectomized Immune Thrombocytopenia (ITP) Patients Receiving Romiplostim or Medical Standard of Care (SOC)
(Abstract No. 569; Oral Presentation; Monday, Dec. 6, 3:45 p.m. EST, Room 340)
- Evaluation of Romiplostim in a Randomized Placebo-Controlled Phase 3 Study of a Japanese Population with Chronic Immune Thrombocytopenia (ITP)
(Abstract No. 3704; Poster III-483; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall A3/A4)
- Impact Assessment of Immunogenicity of Romiplostim in Subjects with Immune Thrombocytopenic Purpura (ITP)
Abstract No. 2517; Poster II-397; Sunday, Dec. 5, 6:00 p.m.-8:00 p.m. EST, Hall A3/A4)
Nplate MDS Data
- Update from an Open-Label Extension Study Evaluating the Long-Term Safety and Efficacy of Romiplostim in Thrombocytopenic Patients (Pts) with Myelodysplastic Syndromes (MDS)
(Abstract No. 1885; Poster I-865; Saturday, Dec. 4, 5:30 p.m.-7:30 p.m. EST, Hall A3/A4)
- Associations Between Platelet Count and Survival and Disease Progression in Thrombocytopenic Patients with Myelodysplastic Syndromes
Abstract No. 2905; Poster II-785; Sunday, Dec. 5, 6:00 p.m. EST, Hall A3/A4)
- Pegfilgrastim Use Associated with Lower Risk of Hospitalization Than Filgrastim Use: A Retrospective US Claims Analysis
(Abstract No. 3801; Poster III-580; Monday, Dec. 6, 6:00 PM-8:00 p.m. EST, Hall A3/A4)
- Underreporting of Myelotoxicity with Emerging Regimens for Selected Hematologic Malignancies
(Abstract No. 1501; Poster I-481; Saturday, Dec. 4, 5:30 p.m.-7:30 p.m. EST, Hall A3/A4)
- Clinic Staff Time and Labor Costs Associated with Administering Pegfilgrastim as Compared with Filgrastim to Patients Receiving Myelosuppressive Chemotherapy: Results of a Health Economic Model
(Abstract No. 1515; Poster I-495; Saturday, Dec. 4, 5:30 p.m.-7:30 p.m. EST, Hall A3/A4)
- Real-Life Cost Analysis of Anemia Treatment with Erythropoiesis Stimulating Agents In Cancer Patients Receiving Chemotherapy
(Abstract No. 3811; Poster III-590; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall A3/A4)