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Takeda Pharmaceuticals' Genetic Disease Therapy Under FDA Probe After Pediatric Patient Dies
(MENAFN- AsiaNet News)
The U.S. Food and Drug Administration (FDA) said on Friday that it is investigating the death of a patient treated with Adzynma.
Adzynma, manufactured by Takeda Pharmaceuticals (TAK), is approved for patients with congenital thrombotic thrombocytopenic purpura (cTTP), also known as Upshaw-Schulman syndrome. It is a rare inherited disorder characterized by a severe deficiency of the ADAMTS13 enzyme.
The death of a pediatric cTTP patient appears to be related to Adzynma, the FDA said. The FDA is now investigating the risk of development of neutralizing antibodies with serious, including life-threatening or fatal, outcomes following treatment with Adzynma.
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