EMA Validates Rigel’s Application for ITP Drug

October 11, 2018

Rare Daily Staff

The European Medicines Agency validated the Marketing Authorization Application for Rigel Pharmaceuticals’ fostamatinib in patients with adult chronic immune thrombocytopenia, a rare, autoimmune condition.

Immune thrombocytopenia (ITP) is a condition in which 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, 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.

Fostamatinib is commercially available in the United States under the brand name Tavalisse. It is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The company anticipates a decision from the Committee on Human Medicinal Products by the fourth quarter of 2019.

“The EMA’s validation of our MAA is an important milestone in the execution of our global commercial strategy for fostamatinib for the treatment of adult chronic ITP,” said Raul Rodriguez, president and CEO of Rigel. “Europe is the second largest ITP market, and we are working diligently to secure a European commercial collaboration in 2019.  We are committed to making fostamatinib available to physicians worldwide for patients affected with chronic ITP.”


October 11, 2018
Raul Rodriguez, president and CEO of Rigel

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