CHMP recommends approval in final guidance for Tavalisse in chronic immune thrombocytopenia.- Rigel Pharma
Rigel Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion for Rigel's Marketing Authorization Application (MAA) for Tavalisse (fostamatinib disodium hexahydrate) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.
The CHMP based its opinion on data provided from the FIT Phase III clinical program, which included two randomized placebo-controlled trials (FIT1 and FIT2) and an open-label extension trial (FIT3). The MAA included data from 163 ITP patients and was supported by a safety database of more than 4,600 subjects across all other indications in which fostamatinib has been evaluated.
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