JW Pharmaceutical Launches "Tavalisse Tab" for Immune Thrombocytopenia Treatment

On July 1, JW Pharmaceutical announced the launch of "Tavalisse Tab" (ingredient: fostamatinib), a treatment for immune thrombocytopenia (ITP).

Immune thrombocytopenia, an autoimmune disorder, occurs when the body's immune system mistakenly attacks platelets as if they were viruses, leading to a decrease in platelet count. This can cause bruising or bleeding, and in severe cases, may result in cerebral hemorrhage or gastrointestinal bleeding. According to medical statistics from the Health Insurance Review and Assessment Service, there were 9,991 ITP patients in Korea as of 2023.

Tavalisse Tab is an innovative oral first-in-class drug that inhibits spleen tyrosine kinase (SYK) to suppress platelet destruction by macrophages. It blocks the process in which ITP develops through SYK activation triggered by Fc gamma (γ) receptor activation, which either activates or suppresses immune responses. Through this mechanism, it effectively improves bleeding symptoms and platelet reduction in ITP patients.

Notably, Tavalisse Tab is the first ITP treatment in Korea with an SYK inhibition mechanism and can be taken regardless of food intake.

Tavalisse Tab was developed by the U.S. pharmaceutical company Rigel Pharmaceuticals and was approved by the U.S. Food and Drug Administration (FDA) in 2018. It was designated as an orphan drug in the United States (2015), Japan (2020), and Korea (2021). In 2018, Kissei Pharmaceutical in Japan secured the rights for development and commercialization from Rigel Pharmaceuticals for Japan, China, Korea, and Taiwan. Accordingly, JW Pharmaceutical signed a License-in agreement with Kissei Pharmaceutical in 2021 for domestic development and sales rights.

JW Pharmaceutical obtained product approval for Tavalisse Tab from the Ministry of Food and Drug Safety in January of this year, and the drug was listed in the reimbursement drug list on June 24. According to the drug price notification, the price for Tavalisse Tab 100mg is set at 23,843 KRW, and for 150mg, it is set at 29,637 KRW.

According to the Korean Society of Hematology's ITP clinical practice guidelines, steroids and immunoglobulins are recommended as first-line treatments. If ITP persists long-term, splenectomy or thrombopoietin receptor agonists (TPO-RA) are used as second-line treatments. However, some patients do not respond adequately to existing therapies, creating a need for new treatment options.

JW Pharmaceutical plans to strengthen its marketing efforts to address the unmet medical needs of ITP patients in Korea with the launch of Tavalisse Tab. A JW Pharmaceutical representative stated, "With the launch of Tavalisse Tab, we are able to provide a new treatment option for ITP patients who have not responded sufficiently to existing therapies. We will continue to work on introducing innovative new drugs to improve patients' quality of life and expand access to medical benefits."