Rigel Pharmaceuticals announced that data from its FIT Phase 3 extension study of fostamatinib in patients with chronic ITP will be presented at the Biennial Summit of the Thrombosis and Hemostasis Societies of North America.
This morning, Rigel Pharmaceuticals announced that data from its FIT Phase 3 extension study (FIT3) of fostamatinib in patients with chronic immune thrombocytopenia (ITP) will be presented at the 4th Biennial Summit of the Thrombosis and Hemostasis Societies of North America between March 8th and 10th in San Diego, California.
Additionally, the company will be presenting preliminary data from its SOAR Phase 2 clinical study in patients with warm antibody autoimmune hemolytic anemia (AIHA).
On March 8 between 3:30 and 4:15 PM PT, Rigel will be presenting its poster, titled “Fostamatinib, a Spleen Tyrosine Kinase Inhibitor, is Active in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia: Results of the SOAR Phase 2, Multicenter, Open-Label Study.” On March 10 at 10:15 AM PT, Rigel will be presenting an oral presentation titled “Platelet Responses in Placebo Patients with Long-Duration Chronic Immune Thrombocytopenia Initiating Fostamatinib in the 049 Open-Label Extension Study.”
A new drug application (NDA) for Fostamatinib is currently being reviewed by the U.S. Food and Drug Administration (FDA) for the treatment of ITP, a rare autoimmune disease where the body destroys its own platelets. Orphan drug designation has been granted for the potential therapy in ITP, but no regulatory action has yet been taken on the second indication. In AIHA, another autoimmune disease, the body destroys its own red blood cells.
Fostamatinib disodium is an oral investigational drug candidate being developed to inhibit spleen tyrosine kinase (SYK), a critical signaling component of the body’s immune process that leads to the destruction of platelets and red blood cells in ITP and AIHA, respectively.
The current standard of care in patients with ITP includes: corticosteroids, splenectomy, immunosuppressants, and thrombopoietin receptor agonist drugs. In the event of life-threatening bleeding, platelet transfusions, IV corticosteroids, IV anti-D immune globulin, or IV immune globulin may be used individually or in combination.
In June, the FDA accepted the NDA for the drug in its lead indication, and Prescription Drug User Fee Act (PDUFA) date was set for April 17, 2018.
Despite the unmet medical need for patients with AIHA, to date, there are no FDA approved disease-targeted therapies for the condition.
At the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in December, Rare Disease Report sat down with Raul Rodriguez, President and CEO of Rigel Pharmaceuticals about the progress of fostamatinib’s development.
“We have orphan designation for our lead indication (ITP) and are going to apply for autoimmune hemolytic anemia and it’s been a tremendous help being able to work with the [FDA] in terms of the review, and also to engage with the patient suffering from this disease and the patient advocacy organization,” he said.
In the video below, he explains the development of the drug, its potential indications and the recent FDA activity surrounding it.