(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 dang

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