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FDA approves Tavalisse ( fostamatinib disodium hexahydrate ) for the treatment of thrombocytopenia

Rigel Pharmaceuticals has obtained its first FDA approval, with a green light to market Tavalisse for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have failed to respond to previous treatment.

Chronic ITP is a rare, autoimmune disease in which the immune system destroys platelets, which are necessary for normal blood clotting. The disorder is difficult to treat because it is impossible to predict how people will respond to available therapies.

Around 50,000-60,000 adults live in the with primary ITP, and many do not respond or stop responding to one or more current therapies, the firm noted, highlighting the unmet need in the area.

Tavalisse (fostamatinib disodium hexahydrate), an SYK inhibitor, has a unique mechanism of action in that it targets the underlying autoimmune cause of the disease by impeding platelet destruction.

“We are excited to bring this new medicine to the population of adult patients with chronic ITP in need of additional therapies,” said Raul Rodriguez, president and chief executive of Rigel.

 

The most common adverse reactions in at least 5% of patients treated with fostamatinib were diarrhea, hypertension, nausea, dizziness, alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia. In the ITP double-blind studies, serious adverse drug reactions were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which each occurred in 1% of patients receiving fostamatinib.

The recommended dose initially is 100 mg administered orally twice daily. After a month, if platelet count has not increased to at least 50×109/L, increase dose to 150 mg twice a day.

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