Rigel Pharmaceuticals, Inc. and Medison Pharma today announced that Health Canada has approved the new drug submission (NDS) for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.
"This approval of TAVALISSE provides ITP patients and physicians in Canada with a new oral treatment option, the only therapy to address the underlying platelet destruction that causes ITP," said Raul Rodriguez, Rigel's president and CEO. "With Medison as our collaborative partner, we believe TAVALISSE is well positioned for commercial success in the Canadian market."
In October 2019, Rigel entered into exclusive license agreements with Medison to commercialize TAVALISSE in Canada and Israel. With the approval from Health Canada, Medison intends to launch TAVALISSE in Canada in Q1 2021. In Israel, a decision on the new drug application (NDA) is anticipated during Q2 2021.
- From Rigel Press Release