FDA investigating death following Adzynma treatment

In a safety communication date November 21, the FDA stated: “Since approval, the Food and Drug Administration has received postmarketing reports of neutralizing antibodies to ADAMTS13, including one death, in congenital thrombotic thrombocytopenic purpura patients treated with Adzynma. Adzynma is a recombinant ADAMTS13 indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura. Adzynma contains two versions of rADAMTS13: native sequence and variant sequence that differs from the native sequence by a single amino acid. The reported death in a pediatric cTTP patient appears to be related to Adzynma… FDA is investigating the risk of development of neutralizing antibodies with serious, including life-threatening or fatal, outcomes following treatment with Adzynma and is evaluating the need for further regulatory action.” Adzynma is marketed by Takeda (TAK).