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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