Story perspectives

FDA Investigates Child’s Death Linked to Takeda’s Adzynma Treatment

11/22/2025

Summary

Story summary

The U.S. Food and Drug Administration (FDA) is investigating a pediatric patient who developed harmful antibodies after treatment with Takeda Pharmaceuticals' Adzynma.
The patient, who had congenital thrombotic thrombocytopenic purpura (cTTP), died about 10 months after treatment.
The FDA has documented multiple cases of neutralizing antibodies against ADAMTS13, the enzyme Adzynma targets.
Takeda Pharmaceuticals says no confirmed causal link, while the FDA weighs action due to post-marketing reports.

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Story summary

The U.S. Food and Drug Administration (FDA) is investigating a pediatric patient who developed harmful antibodies after treatment with Takeda Pharmaceuticals' Adzynma.
The patient, who had congenital thrombotic thrombocytopenic purpura (cTTP), died about 10 months after treatment.
The FDA has documented multiple cases of neutralizing antibodies against ADAMTS13, the enzyme Adzynma targets.
Takeda Pharmaceuticals says no confirmed causal link, while the FDA weighs action due to post-marketing reports.