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Rigel Receives EMA Validation for Fostamatinib

October 12, 2018 By americanpharmaceuticalreview

Rigel Pharmaceuticals announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for fostamatinib in adult chronic immune thrombocytopenia. The validation was received on October 4, 2018 and initiated the MAA review process. The company anticipates a decision from the Committee on Human Medicinal Products by the fourth quarter of 2019. Currently, fostamatinib is commercially available in the U.S. under the brand name Tavalisse (fostamatinib disodium hexahydrate), which 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 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."

The MAA review follows the U.S. Food and Drug Administration (FDA) approval and commercial launch in the U.S. of Tavalisse.

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