What is the global launch status of fotantinib/fotantinib?

Fostamatinib (Fostamatinib) is an innovative oral splenic tyrosine kinase (SYK) inhibitor, mainly used to treat adult patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to previous treatments. Since being approved by the U.S. Food and Drug Administration (FDA) on April 17, 2018, the global marketing status of fotantinib is as follows:

In the United States, fotantinib is marketed under the trade nameTAVALISSE and is manufactured and sold by Rigel Pharmaceuticals. The drug's approval was based on two double-blind, placebo-controlled clinical trials (FIT-1 and FIT-2), which showed that fotantinib had significant efficacy in increasing platelet counts in patients with chronic ITP.

In Europe, fotantinib is marketed under the trade nameTAVLESSE and is commercialized by Grifols. The drug has been approved in several European countries, including the United Kingdom, Germany, France, Italy, Spain, Norway and the Czech Republic. The National Institute for Health and Care Excellence (NICE) has recommended TAVLESSE for the treatment of adult patients with chronic ITP who have had an inadequate response to previous treatments.

In Canada, fotantinib has also been approved for the treatment of patients with chronicITP. In Japan, Kissei Pharmaceutical submitted a marketing application for fotantinib on April 27, 2022, for the treatment of patients with chronic ITP. The application is based on positive results from a Phase III clinical trial conducted in Japan.

In addition,Kissei Pharmaceutical has also obtained the development and commercialization rights of fotantinib in China, South Korea and other countries. In these regions, the marketing application and approval of fotantinib is in progress. The global launch of fotantinib reflects its potential and value in the treatment of chronic ITP. With approval in more countries and regions, fotantinib is expected to provide new treatment options for more patients.

Reference materials:https://go.drugbank.com/drugs/DB12010