FDA's an­timi­cro­bial ad­comm unan­i­mous­ly backs Takeda's drug for post-trans­plant cy­tomegalovirus

The FDA’s an­timi­cro­bial drugs ad­vi­so­ry com­mit­tee on Thurs­day vot­ed unan­i­mous­ly in fa­vor of FDA ap­prov­ing Take­da’s an­tivi­ral for post-trans­plant cy­tomegalovirus.

The ad­comm vot­ed 17-0 on the ques­tion of whether the over­all ben­e­fit-risk pro­file is fa­vor­able for the use of Take­da’s marib­avir for the treat­ment of trans­plant re­cip­i­ents with CMV in­fec­tion and dis­ease re­frac­to­ry to treat­ment and with geno­typ­ic re­sis­tance to four oth­er an­tivi­rals — gan­ci­clovir, val­gan­ci­clovir, fos­car­net or cid­o­fovir.

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