FDA of­fers sup­port for Takeda's po­ten­tial cy­tomegalovirus drug ahead of ad­comm

Af­ter al­most two decades of dis­cus­sions with FDA re­gard­ing the de­vel­op­ment of Take­da’s po­ten­tial drug for post-trans­plant cy­tomegalovirus (CMV), which it bought in its ac­qui­si­tion of Shire in 2019, the agency seems to be of­fer­ing pos­i­tive marks for the drug’s safe­ty and ef­fi­ca­cy pro­file ahead of Thurs­day’s ad­comm.

Ac­cord­ing to FDA’s brief­ing doc­u­ments re­leased ahead of the meet­ing, marib­avir proved safe across mul­ti­ple stud­ies and sta­tis­ti­cal­ly su­pe­ri­or to in­ves­ti­ga­tor-as­signed treat­ment (IAT) in a Phase III tri­al, which Take­da an­nounced ear­li­er this year.

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