In May 2018, TAVALISSE was approved by the U.S. Food and Drug Administration (FDA) for use in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The patent for TAVALISSE expires in 2026, with an anticipated extension for patent restoration to 2032. We plan to take advantage of this long window of exclusivity and further explore its potential.
Currently, TAVALISSE is in a Phase 3 clinical trial for the treatment of warm antibody autoimmune hemolytic anemia (AIHA) and a Phase 3 clinical trial for the treatment of hospitalized COVID-19 patients.
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 Antibody AIHA: