Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug
The FDA will review Takeda’s enzyme replacement therapy for an ultra-rare blood clotting disorder and decide whether to approve it within six months, the Japanese drugmaker said Wednesday.
The agency gave priority review to Takeda’s TAK-755, which was shown to reduce instances of low blood platelet count in an interim look at Phase III data back in early January. The trial included adolescents and adults with congenital thrombotic thrombocytopenic purpura (cTTP) and compared the ERT to standard plasma-based therapies.
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