Takeda adds boxed warning on ADZYNMA over risk of neutralizing antibodies to ADAMTS13
TAK•Takeda adds boxed warning to ADZYNMA label
Takeda updated the U.S. prescribing label for ADZYNMA to add a boxed warning on neutralizing antibodies to ADAMTS13.
- Post-approval reports linked neutralizing antibodies to serious outcomes, including death, raising the risk of reduced or no response to ADAMTS13 therapy.
- Clinical trials in congenital TTP did not report neutralizing antibodies; the label already flagged immunogenicity risk, but the warning is now elevated.
- Guidance calls for close monitoring of ADAMTS13 activity, baseline testing for neutralizing antibodies, and periodic reassessment during treatment.
- Takeda said ADZYNMA’s overall benefit-risk profile remains favorable; the product remains the only FDA-cleared recombinant ADAMTS13 replacement for cTTP.
