Romiplostim is under clinical development by Amgen and currently in Phase III for Thrombocytopenia. According to GlobalData, Phase III drugs for Thrombocytopenia have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Romiplostim’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Romiplostim (Nplate), is an Fc-peptide fusion protein. It is formulated as lyophilized powder for solution for subcutaneous route of administration. Nplate is indicated for treatment of adults, and pediatrics 1 year and older with long-term immune thrombocytopenic purpura (ITP), and for the treatment of aplastic anemia (AA) in patients who have had an inadequate response to conventional therapy in adults and also indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation. Nplate (romiplostim for injection) is indicated to increase the platelet levels in adult patients with immune thrombocytopenia (ITP):who are nonsplenectomized and have had an inadequate response or are intolerant to corticosteroids and/or immunoglobulins; who are splenectomized and have had an inadequate response to splenectomy
Romiplostim is under development for chemotherapy-induced thrombocytopenia, immune thrombocytopenic purpura for adults in China and aplastic anemia . It was also under development for myelodysplastic syndrome.
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.
For a complete picture of Romiplostim’s drug-specific PTSR and LoA scores, buy the report here.