JW Pharmaceutical announced on the 21st that its immune thrombocytopenia (ITP) treatment 'Tavalisse 100·150mg (active ingredient fostamatinib)' received product approval from the Ministry of Food and Drug Safety the previous day. The Ministry of Food and Drug Safety approved the prescription of Tavalisse for adult patients who have not responded well to existing treatments.
Chronic immune thrombocytopenia is an autoimmune disease where the body's immune system mistakenly attacks platelets, causing a decrease in platelet count below the normal range. This condition can easily lead to bruising or bleeding, and in severe cases, it may result in brain or gastrointestinal bleeding.
Tavalisse is a first-in-class innovative drug that works by inhibiting the 'spleen tyrosine kinase (Syk)', a signaling protein that regulates various biological functions in the body, thereby impeding platelet destruction. Developed by the American pharmaceutical company Rigel Pharmaceuticals, it obtained approval from the U.S. Food and Drug Administration in 2018 and was designated as an orphan drug in the U.S., Japan, and South Korea. That same year, Japan's Kissei Pharmaceutical secured the development and commercialization rights from Rigel Pharmaceuticals, and JW Pharmaceutical signed a license-in agreement with Kissei Pharmaceutical in 2021 to secure domestic rights.
JW Pharmaceutical plans to officially launch the product starting in June of this year after completing the insurance pricing registration process for Tavalisse. A company official noted, 'Tavalisse can be taken regardless of meals and has no restrictions on drug-drug interactions (DDI), significantly enhancing patient convenience.'
Meanwhile, JW Pharmaceutical is actively pursuing a license-in strategy to secure development and sales rights for new drug candidates currently in clinical trials overseas, in addition to its own drug development. Notable examples include the cholesterol-lowering drug 'Rivaro', the hemophilia A treatment 'Hemlibra', and the rheumatoid arthritis treatment 'Actemra'.