In November 2020, Rigel received approval from Health Canada for its new drug submission (NDS) for fostamatinib for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. The product launched in December 2020 and is marketed in Canada under the brand name TAVALISSE®. It is the first and only spleen tyrosine kinase (SYK) inhibitor approved in Canada for this indication.
In August 2021, the Israel Ministry of Health approved the new drug application (NDA) submitted for TAVALISSE (fostamatinib disodium hexahydrate) for the treatment of ITP. TAVALISSE is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
Rigel received an upfront payment, which included an advanced royalty payment, and is eligible for regulatory and commercial milestone payments, as well as tiered royalty payments on any future net sales of any products emerging from the collaboration.