Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Re­searchers still have key ques­tions about Ei­sai’s in­ves­ti­ga­tion­al Alzheimer’s drug lecanemab fol­low­ing the pub­li­ca­tion of more Phase III da­ta in the New Eng­land Jour­nal of Med­i­cine Tues­day night.

In the pa­per, which was re­leased in con­junc­tion with pre­sen­ta­tions at an Alzheimer’s con­fer­ence, tri­al in­ves­ti­ga­tors write that a de­f­i­n­i­tion of clin­i­cal mean­ing­ful­ness “has not been es­tab­lished.” And the rel­a­tive lack of new in­for­ma­tion, fol­low­ing topline da­ta un­veiled in Sep­tem­ber, left ex­perts ask­ing for more — set­ting up a po­ten­tial show­down to pre­cise­ly de­fine how big a dif­fer­ence the drug makes in pa­tients’ lives.

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