Rigel pharmaceutical tavalisse is FDA approved for the treatment of chronic thrombocytopenia

Source: Sina Pharmaceutical News April 17, 2018, Rigel pharmaceutical announced that the US FDA has approved tavalisse Gamma It was used in the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who had not been treated well before Tavalisse is an oral Syk inhibitor It can prevent the destruction of platelets to deal with the potential autoimmune causes of the disease, which provides an important new treatment for adult patients with chronic ITP Rigel plans to launch the drug in the United States in late May 2018 "Chronic ITP," said Dr James Bussel, Professor of pediatrics at Cornell School of medicine, principal investigator of the fit phase 3 trial, consultant and paying member of the Rigel pharmaceutical Advisory Committee Because of the heterogeneity of the disease, it is difficult to predict how individual patients respond to the available treatment Not all patients can find a good treatment Tavalisse's FDA approval gives clinicians a therapeutic drug with a new mechanism of action " Tavalisse's approval relies on data from fit clinical studies, which included two randomized placebo-controlled clinical phase 3 studies 047 and 048, an extended bid opening trial 049, and an initial proof of concept trial The new drug listing application includes data of 163 ITP patients and is supported by a safety data set, which contains more than 4600 subjects who have been evaluated by tavalisse for other indications "People with chronic ITP often feel that they have an invisible disease that not only affects their quality of life, but also threatens their lives," said Caroline Kruse, executive director of the platelet disorders support association That's why we encourage our community members to understand their diseases, understand treatment strategies, and seek support so that they can have the best care The approval of this new drug provides a new choice for the ITP medical community " Platelets play an active role in coagulation and healing, but in ITP patients, the immune system attacks and destroys its own platelets Common symptoms of ITP include excessive bruising, bleeding, and fatigue People with chronic ITP may increase the risk of serious bleeding events, which can lead to serious medical complications or even death At present, the treatment of ITP includes steroid, thrombopoietin and splenectomy However, not all patients have sufficient response to the current treatment Therefore, for ITP patients, there is still a great need for additional treatment.