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.
COVID-19 is an infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2
SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcyR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.
Development of TAVALISSE (fostamatinib) in COVID-19: