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Details:
TAVALISSE (fostamatinib disodium hexahydrate) is a prescription medication used to treat adults with low platelet counts due to chronic ITP. Fostamatinib is also being evaluated in an ongoing study of patients who are experiencing more severe COVID-19-related complications.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Details:
Fostamatinib, commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is the first and only FDA-approved SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Immunology Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
Results demonstrate clinically meaningful hemoglobin responses and a safety and tolerability profile consistent with existing tavalisse, an oral spleen tyrosine kinase (SYK) inhibitor, rapidly and durably increased hemoglobin (Hgb) levels, safety database.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Immunology Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
The Phase 3 clinical study (n=34) showed that patients receiving Tavalisse(Fostamatinib Disodium Hexahydrate) achieved a stable platelet response significantly higher than patients receiving a placebo control for the treatment of adult chronic immune thrombocytopenia.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Immunology Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kissei Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2021
Details:
The study met the primary endpoint showing fostamatinib did not increase the incidence of serious adverse events (SAEs) compared with placebo.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2021
Details:
Fostamatinib is an oral drug designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the autoimmune process that leads to platelet destruction in immune thrombocytopenia (ITP).
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Immunology Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2021
Details:
This study follows a recently completed NHLBI/NIH-sponsored Phase 2 study , with positive topline results, that evaluated fostamatinib in hospitalized adults with COVID-19.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2021
Details:
Fostamatinib reduced the incidence of Serious Adverse Events (SAEs) by half. By day 29, there were three SAEs in the fostamatinib plus standard of care (SOC) group of thirty patients compared to six SAEs in the placebo plus SOC group of twenty-nine patients.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2021
Details:
The Phase 3 clinical trial will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Department of Defense
Deal Size: $16.5 million Upfront Cash: Undisclosed
Deal Type: Funding January 29, 2021
Details:
Health Canada has approved the new drug submission for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Immunology Product Name: Tavalisse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
Rigel received approval from the FDA for its Phase 3 clinical trial of fostamatinib disodium hexahydrate in warm autoimmune hemolytic anemia, to include proposed durable response measure for the primary efficacy endpoint and inclusion of additional secondary endpoints.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Hematology Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
The NIH/NHLBI-Sponsored trial is a randomized, double-blind, placebo-controlled trial to evaluate the safety of fostamatinib for the treatment of hospitalized COVID-19 patients.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
This is a randomized, double-blind, placebo-controlled trial to evaluate the safety of fostamatinib for the treatment of hospitalized COVID-19 patients.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Tavalisse
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Heart, Lung, and Blood Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
TAVLESSE, which is marketed in the U.S. under the brand name TAVALISSE®, is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP by impeding platelet destruction.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Immunology Product Name: Tavalisse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Grifols International
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% achieved ≥1 platelet count of ≥50,000/µL. Adverse events were manageable and consistent with those previously reported with fostamatinib.
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Hematology Product Name: Tavalisse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
Rigel is exploring opportunities to collaborate with research institutes to investigate the potential of TAVALISSE to treat COVID-19 pneumonia and related acute respiratory distress syndrome (ARDS).
Lead Product(s): Fostamatinib Disodium Hexahydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 05, 2020
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