Posted by Michael Wonder on 17 May 2023
US FDA grants priority review of TAK-755 for the treatment of congenital thrombotic thrombocytopenic purpura
16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation and orphan drug designation in congenital thrombotic thrombocytopenic purpura.
Takeda today announced that the US FDA has accepted Takeda’s biologics license application for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura, an ADAMTS13 deficiency disorder. The TAK-755 application was accepted by the FDA on 16 May and has been granted priority review.
