SOUTH SAN FRANCISCO, Calif. and PETACH TIKVA, Israel, Nov. 23, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) and Medison Pharma (Medison) 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.
"Our multiregional partnership with Rigel to deliver TAVALISSE in Canada and Israel is a testament to our ongoing efforts to extend the reach of highly innovative therapies to patients across international markets," said Meir Jakobsohn, founder and CEO of Medison Pharma.
"Given our specialization in delivering cutting-edge therapeutics, TAVALISSE is a natural fit for Medison's expertise and will enable us to bring a much-needed treatment option to Canadian ITP patients," said Joe O'Neill, GM of Medison Canada.
Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.
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