When will fostatinib/fotantinib be released on the market?

Fostamatinib (Fostamatinib), trade name Tavalisse, is a targeted drug developed by Rigel Pharmaceuticals. It is mainly used to treat chronic immune thrombocytopenia (ITP). Fostatinib was approved by the US FDA in April 2018 for the treatment of ITP, especially in adult patients who have failed traditional treatments. As a Syk enzyme inhibitor, fostatinib modulates the immune system and reduces the attack on platelets, thereby increasing the number of platelets and significantly reducing the patient's risk of bleeding.

After being approved byFDA, fostatinib has brought new hope to patients with immune thrombocytopenia as a new treatment option. It is authorized as an "orphan drug" for the treatment of ITP, which means that fostatinib's clinical use in this area has received special regulatory support to facilitate its development and marketing. Orphan drug designation is usually applied to drugs that treat rare diseases, which usually have a small market size and a large clinical need. The launch of fostatinib has filled the treatment gap for ITP patients when other treatments are ineffective.

Although fostatinib is approved in the United States, the drug is not currently available in China. Drug approval times vary in different countries and regions, and fostatinib still needs to go through the approval process of the China National Medical Products Administration (NMPA) before it can enter the market. With the gradual improvement of the global drug regulatory system and the expansion of the international market, the launch of fostatinib in other countries and regions is also progressing.

In short, fostatinib was approved by the FDA on April 17, 2018, and became an innovative drug for the treatment of immune thrombocytopenia. Although it is already available in some countries and regions, it is not yet officially sold in the Chinese market. As the relevant approval procedures proceed, fostatinib is expected to provide treatment options for patients in more countries and regions.

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