New Beijing News (Reporter Zhang Zhaohui) On December 30th, the official website of the Drug Evaluation Center of the National Medical Products Administration announced that the application for the listing of Class 1 new drug rilzbrutinib tablets jointly submitted by Sanofi and Genzyme has been accepted.
Public information shows that rilzabrutinib is an oral, reversible covalent BTK inhibitor that can selectively inhibit BTK targets while potentially reducing the risk of off target side effects. In November of this year, Sanofi announced the positive results of its Phase 3 clinical trial for indications of immune thrombocytopenia (ITP) at the American Society of Hematology (ASH) annual meeting. Sanofi previously stated that rilzabrutinib has the potential to become the first BTK inhibitor for the treatment of ITP indications. The product is currently undergoing regulatory review in the United States and the European Union.
This therapy has also been granted fast track and orphan drug status by the US FDA for the treatment of ITP. In addition to the indications for ITP, the product is also undergoing phase 2 clinical trials for chronic spontaneous urticaria, asthma, IgG4 related diseases, warm antibody type autoimmune hemolytic anemia, and other conditions.