Fostamatinib disodium is under clinical development by Rigel Pharmaceuticals and currently in the Phase I, 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 Fostamatinib disodium’s likelihood of approval (LoA) and phase transition for Acquired (Autoimmune) Hemolytic Anemia took place on 15 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Fostamatinib disodium Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Fostamatinib disodium overview
Fostamatinib disodium (Tavalisse, Tavlesse) is an immunomodulating agent. It is formulated as film-coated tablets for oral route of administration. Tavalisse is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
It is also under development for the treatment of hidradenitis suppurativa, acquired (autoimmune) hemolytic anemia, myelofibrosis with severe thrombocytopenia, pneimonia due to COVID-19 disease, platinum-resistant ovarian, fallopian tube, antibody mediated rejection in renal transplantation, and primary peritoneal cancer.It was also under development for the treatment of IgA nephropathy (Berger's disease), rheumatoid arthritis, systemic lupus erythematosus (SLE) and hematological malignancies such as diffuse large B-Cell lymphoma, relapsed or refractory T-Cell lymphoma.
Rigel Pharmaceuticals overview
Rigel Pharmaceuticals (Rigel), is a biotechnology company that discovers and develops innovative small-molecule drugs for patients with immune disorders, hematological disorders, cancer and rare diseases. Its research activities focus on signaling pathways that are critical to disease mechanisms. The company’s lead product, the US FDA-approved Tavalisse (fostamatinib disodium hexahydrate), is an oral spleen tyrosine kinase inhibitor to treat adult patients with chronic immune thrombocytopenia. Rigel is also evaluating Fostamatinib for autoimmune hemolytic anemia and IgA nephropathy in Phase II trials. The company has partnered clinical programs with Aclaris, BerGenBio, Daiichi, AstraZeneca, Kissei, Grifols, Merck and Novartis. Rigel is headquartered in South San Francisco, California, the US.
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