Romiplostim is under clinical development by Amgen and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Romiplostim’s likelihood of approval (LoA) and phase transition for Thrombocytopenia took place on 04 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Romiplostim Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
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.
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