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Nov 21, 2025 4:00 PM

FDA Flags Antibody Risk After Child's Death Linked To Takeda's Enzyme Replacement Therapy For Rare Blood Disorder

The U.S. Food and Drug Administration (FDA) on Friday said it has received postmarketing reports of neutralizing antibodies to ADAMTS13 in patients treated with Adzynma (recombinant ADAMTS13), including one pediatric death.

Takeda Pharmaceutical Co., Ltd. (NYSE:TAK) Adzynma is approved as a prophylactic or on-demand enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP) and contains two rADAMTS13 variants—one native and one with a single amino-acid modification.

A genetic mutation causes cTTP, which is a rare disorder.

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