Mer­ck tees up US/Eu­ro­pean ap­pli­ca­tions for leter­movir af­ter de­tail­ing PhI­II an­tivi­ral suc­cess

Mer­ck has un­veiled the pos­i­tive da­ta be­hind its Phase III win for its an­tivi­ral leter­movir. While it’s no panacea, the drug clear­ly out­per­formed a place­bo in chop­ping down on the num­ber of CMV in­fec­tions suf­fered in the tar­get pop­u­la­tion of pa­tients. And now Mer­ck plans to file for an ap­proval lat­er this year in Eu­rope as well as the US.

In­ves­ti­ga­tors re­cruit­ed 495 CMV-seropos­i­tive pa­tients who re­ceived a bone mar­row trans­plant for the study, and tracked a 37.5% rate of CMV in­fec­tions among the pa­tients tak­ing leter­movir. In the place­bo arm, the rate of in­fec­tions was 60.6% at 24 weeks. And a key sec­ondary — clin­i­cal­ly sig­nif­i­cant CMV in­fec­tions — clear­ly fa­vored Mer­ck’s drug: 19.1% com­pared to 50%.

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