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Full Letter From Takeda to the National MPS Society
On behalf of Takeda, we are writing to share some disappointing news with the Hunter syndrome community regarding Takeda’s investigational intrathecal enzyme replacement therapy (ERT), TAK-609, for the potential treatment of pediatric patients with Hunter syndrome (mucopolysaccharidosis II / MPS II) and cognitive impairment.
After an eight-year journey, Takeda has made the difficult decision to discontinue development of TAK609 and will not proceed with regulatory submissions to the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authorities. We recognize this is not the decision we all hoped for when Shire (acquired by Takeda in 2019) set out to find a treatment that could address the debilitating cognitive effects of this disease. Several members of our Takeda team have been working on this program, alongside the MPS II patient community, since the beginning, so we understand the sadness we all share about this outcome.
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