According to the FDA, the patient who recently died after receiving Adzynma had previously experienced severe allergic reactions to fresh frozen plasma. After starting treatment, the patient developed neurological symptoms that gradually worsened, and ten months later, neutralizing antibodies were detected.
FDA launches investigation into gene therapy following child death
The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The incident is described as likely related to the drug.