Nov 21 (Reuters) - The U.S. Food and Drug Administration
is probing the death of a patient who developed harmful
antibodies after taking Takeda Pharmaceuticals' blood
disorder therapy, the health regulator said on Friday.
The pediatric patient died about 10 months after starting
Takeda's drug Adzynma as a preventive therapy, the agency said.
The child had congenital thrombotic thrombocytopenic purpura
(cTTP), an inherited condition that causes blood clots in small
vessels and can lead to organ damage.
The FDA said the child developed antibodies that blocked the
activity of ADAMTS13, an enzyme critical for blood clotting.
Takeda did not immediately respond to Reuters request for
comment.
Adzynma, approved in 2023 as the first therapy for cTTP,
replaces the ADAMTS13 protein to help prevent dangerous blood
clots.
The agency added it has received multiple postmarketing
reports of patients developing neutralizing antibodies to
ADAMTS13 after treatment with Adzynma.