Take­da tees up pri­or­i­ty re­view for sto­ried CMV drug from its $62B Shire buy­out

One of the Shire drugs that Take­da spot­light­ed in its $62 bil­lion takeover is get­ting a speedy look at the FDA.

The drug, marib­avir, is be­ing po­si­tioned as the first and on­ly treat­ment for re­frac­to­ry post-trans­plant cy­tomegalovirus in­fec­tion — af­ter a wild 20-year ride that saw it fail stud­ies and get aban­doned while oth­er Big Phar­ma ef­forts al­so crashed.

For the Japan­ese phar­ma gi­ant, a suc­cess here would al­so bring much-need­ed val­i­da­tion in a cru­cial year in which it’s plot­ting six reg­u­la­to­ry fil­ings and ex­pect­ing four ap­provals. Two oth­ers have al­ready lined up at the FDA in re­cent months, in­clud­ing TAK-721 for eosinophilic esophagi­tis and mobo­cer­tinib for EGFR Ex­on20 in­ser­tion mu­ta­tion pos­i­tive non-small cell lung can­cer. A third, the dengue vac­cine can­di­date TAK-003, has been sub­mit­ted to the EMA.

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