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Rigel Receives Positive Trend Vote from CHMP for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe
SOUTH SAN FRANCISCO, Calif., Oct. 18, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the Committee for Medicinal
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Oct. 18, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive trend vote on the Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib). The indication for the positive trend vote is for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.\n\"During the EMA review process for fostamatinib in adult chronic ITP, we have had very constructive interactions with the committee,\" said Raul Rodriguez, president and CEO of Rigel. \"We are pleased with this positive trend vote from the CHMP this week, which brings us one step closer to potentially providing a new therapeutic option for a patient population that has a clear unmet clinical need.\"\nThe CHMP intends to hold a final vote on their recommendation at their November meeting. Pending a formal positive CHMP opinion, the European Commission, which has the authority to approve medicines for use in Europe, would be expected to render their decision approximately 60 days after the opinion is received.\nFostamatinib is commercially available in the U.S. and is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in U.S. adult patients with chronic ITP who have had an insufficient response to a previous treatment. Europe is the second largest market for adult chronic ITP treatments after the United States.\nAbout ITP\nIn patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (Thrombopoietin Receptor Agonists) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.\nAbout Rigel (www.rigel.com)\nRigel Pharmaceuticals, Inc., is a biotechnology co...