Warm AIHA

TAVALISSE®​ (fostamatinib disodium hexahydrate) is a selective, oral spleen tyrosine kinase (SYK) inhibitor being evaluated in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA).

*TAVALISSE is not FDA-approved for use in warm AIHA.

Autoimmune Hemolytic Anemia (AIHA)

AIHA is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction (hemolysis) of the body’s own red blood cells (RBC). In AIHA, the body destroys RBCs at a greater rate than it can produce new RBCs, eventually leading to anemia (low levels of red blood cells), with symptoms such as fatigue, pale color, rapid heartbeat, and shortness of breath. In severe cases fever, chest pain, fainting, or heart failure may occur. AIHA affects approximately 45,000 adult patients in the U.S. and approximately 1 to 3 in 100,000 adults are diagnosed each year. Warm antibody AIHA is the most common form of AIHA and can be either primary or secondary to an underlying disease such as systemic lupus erythematosus (SLE) or a lymphoproliferative condition such as or chronic lymphocytic leukemia (CLL) or lymphoma. To date, there are no approved therapies for AIHA, despite the unmet medical need.

Development of TAVALISSE (fostamatinib) in warm AIHA:

  • Phase 3 clinical trial (FORWARD) enrollment is complete
    • Topline data from the 24-week study was released in June 2022.
    • The open-label extension study is ongoing (NCT04138927)
  • The FDA has granted both Orphan Drug designation and Fast Track designation to TAVALISSE for this indication
  • Data from the Phase 2 clinical study of fostamatinib for the treatment of warm AIHA in adults was published in the American Journal of Hematology