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US FDA investigates Takeda's blood disorder drug after pediatric death
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US FDA investigates Takeda's blood disorder drug after pediatric death
Nov 21, 2025 9:15 AM

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.

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