Posted by Michael Wonder on 11 Oct 2018
Rigel receives EMA validation of the marketing authorisation application for fostamatinib disodium hexahydrate in chronic immune thrombocytopenia in adult patients
11 October 2018 - First SYK inhibitor for the treatment of adult chronic ITP.
Rigel Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for fostamatinib in adult chronic immune thrombocytopenia. The validation was received on 4 October 2018 and initiated the application 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 Tavalissse (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.
