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Rigel seeks EU approval on drug for low blood platelet count disorder

Rigel Pharmaceuticals Inc. said the European Medicines Agency validated its application for fostamatinib to treat adult patients with a condition that lowers the platelet count in the blood.

The South San Francisco, Calif.-based company is seeking European approval for fostamatinib to treat adult patients with chronic immune thrombocytopenia — a bleeding disorder in which the blood does not clot due to the low number of platelets — and who received a prior treatment but had an insufficient response.

Following validation, the company's marketing authorization application is now under review. The EU agency's Committee on Human Medicinal Products is expected to release its decision by the fourth quarter of 2019.

The drug is approved and marketed in the U.S. as Tavalisse for thrombocytopenia.