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Phase III trial of Tavalisse meets primary endpoint in chronic immune thrombocytopenia.

Read time: 1 mins
Published:22nd Dec 2021
Rigel Pharmaceuticals announced that its collaboration partner, Kissei Pharmaceutical has released positive topline results from its Phase III clinical trial in Japan evaluating Tavalisse (fostamatinib disodium hexahydrate) for the treatment of adult chronic immune thrombocytopenia (ITP).

The Phase III clinical study (n=34) showed that patients receiving fostamatinib (R788) achieved a stable platelet response significantly higher than patients receiving a placebo control.

A stable platelet response was defined as achieving greater than or equal to 50,000 platelets per microL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment. The safety profile of fostamatinib was consistent with other clinical trials, with no new or unusual safety issues observed.

In October 2018, Rigel entered into an exclusive license and supply agreement with Kissei to develop and commercialize fostamatinib in all current and potential indications in Japan, China, Taiwan and the Republic of Korea.

Condition: Chronic Immune Thrombocytopenia
Type: drug

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