Eltrombopag olamine is under clinical development by Novartis and currently in the Phase II and 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 Eltrombopag olamine’s likelihood of approval (LoA) and phase transition for Radiation Toxicity (Radiation Sickness, Acute Radiation Syndrome) took place on 03 Feb 2021, 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 Eltrombopag olamine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Eltrombopag olamine overview
Eltrombopag olamine (Revolade/ Promacta/ Revoleyd/ Rebozet) is a small-molecule, nonpeptide thrombopoietin receptor agonist. It is formulated as film coated tablets and powder for suspension for oral route of administration. Promacta is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon -based therapy, for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who has had an insufficient response to corticosteroids, immunoglobulins, or splenectomy and chemotherapy-induced thrombocytopenia in solid tumors. It is also indicated for the treatment of severe aplastic anemia. Promacta is also used for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy, for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Revolade is also indicated for the treatment of severe aplastic anemia (SAA), for the treatment of pediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins, and also as first-line treatment for adults and pediatric patients two years and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST).
Eltrombopag olamine is under development for acute myelocytic leukemia, chronic immune (idiopathic) thrombocytopenia (ITP), Fanconi anemia, severe aplastic anemia and hematopoietic sub-syndrome of acute radiation syndrome (H-ARS). It was also under development for the treatment of relapsed/refractory acute myelocytic leukemia and myelodysplastic syndrome.
It is also under development for myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML), anemia
Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.
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