May 17, 2023 10:56 AM EDT

Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug

Max Gelman

Senior Editor

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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Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug

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Max Gelman

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Pri­or­i­ty re­view for Take­da’s ul­tra-rare blood clot ERT; FDA to give an­oth­er look at Arde­lyx’s CKD drug

Associate Editor

Senior Editor

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Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug