TAK - Back To Back FDA Approval For Takeda Within Two Days Secures Green Signal For Rare Blood Disorder Therapy | Benzinga
The FDA approved Takeda Pharmaceutical Co Ltd's (NYSE: TAK) Adzynma, a recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP).
cTTP is an ultra-rare, chronic blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme.
The FDA approval of Adzynma was supported by data from the Phase 3 trial in cTTP and data from the ...