Rigel and Medison Announce Health Canada Approval of TAVALISSE®

IndustryPRwire -- Rigel Pharmaceuticals and Medison Pharma 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.

Raul Rodriguez, Rigel's president and CEO Commented "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, 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.  

Meir Jakobsohn, founder and CEO of Medison Pharma Commented "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."

Joe O'Neill, GM of Medison Canada Commented "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."

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.

About ITP

In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

Related Posts

Subscribe Our Newsletter