Promacta is under clinical development by Novartis and currently in Phase III for Radiation Toxicity (Radiation Sickness, Acute Radiation Syndrome). According to GlobalData, Phase III drugs for Radiation Toxicity (Radiation Sickness, Acute Radiation Syndrome) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Promacta’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.
Promacta overview
Eltrombopag olamine (Revolade / Promacta / Rebozet / Eltrombopag Ethanolamine) is a small-molecule, nonpeptide thrombopoietin receptor agonist. It is formulated as tablets, 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 overview
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, hematologic diseases, solid tumors, immune disorders, and infections, among others. Novartis conducts research in various disease areas through the BioMedical Research division. 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.
For a complete picture of Promacta’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
