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.

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; and Rezlidhia (olutasidenib) for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation. 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.

For a complete picture of Fostamatinib disodium’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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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.